ELTP Alerts 08/19/2014 10:31:15 $ELTP
I will just take the word of the FDA. thNKA
http://www.fda.gov/NewsEvents/Newsroom/PressA...406407.htm
Actually agree 100%.
Fast track from there, GLTA
Holding .31 good support there
lasers, no doubt. we live or die with fda decision
I am left with my observation that regarding generics
they are merely a hobby of elite and seem to be tinkered
puttered around with, as a way to relax from the real work
at hand our art drugs, I get it, but would like to have seen
cash flow positive on generic side of busin. which at one time
would have brought us to 1-2 bucks on their own if serious concern
work hours were thrown to that division
snup dawg
Quote:
I'm buying today at .305 and .285
yeah right...why .305 if you think its going as low as .285 ?
snupoled. The meat on the bone is coming for $ELTP. The planned meeting with the FDA in Sept/Oct is like 110% positive for ELI-200 which will be $ELTP FLAGSHIP first ART/ADT.
thanks Lasers,
I guess I want more meat on the bone concerning "being on track"
with all our generics....
snup
Doug Plassche has done a marvellous job in securing the API for Isradipine. It has been a very difficult process and the supplier of Isradipine wanted to be assured that $ELTP would take the entire batch for Isradipine starting API. The only other seller of Isradipine is Actavis/Watson. Doug Plassche is a leading expert on Isradipine from his employment at Actavis. $ELTP is very blessed to have such a talented VP of Operations Doug Plassche.
Quote:
any disappointment in q-4 launch of isradipine?
None whatsoever! $ELTP is on track with its Generics and ART/ADT ELI drugs
Lasers,
what is your take on generics, what is the timeline on them?
any disappointment in q-4 launch of isradipine?
snup
Well that is good advice- assume that you are going to lose your entire investment before you invest- uh? My plan was to never lose a dime thank you
conix TOTAL NONSENSE! Targiniq ER is a co-drug to relieve OIC (Opioid Induced Constipation) It was thoroughly discussed a few weeks back in several of my posts.
The Naloxone is NOT on standby for abuse deterrence but is CO-RELEASED with the Oxycodone to partially block ONLY the Intestinal mu receptors to prevent OIC!!!!!
John,
with generics I am in agreement, what was said vs.q4 launch is
disappointing, also no time line on other generics makes it feel
like we may be deep into 2015 before they launch..
but,
our Ceo is not hear for what I think he sees as a hobby
the generic side of business, so
We live or die by thumbs up thumbs down scenario
awesome news would be , not paying attention to generics
because there is serious discussions of buy out and company
doesn't want the launches until they take over...
anyways,
plan accordingly, I believe we will be much higher on dec.31 2014
than we are now. why snup, because we will see clearly the outline
of our first product, we will know partner news, and we will have
data,,,,we live or die by fda decisions
snup
snup dawg , good morning board,,
fair and balanced,
I was disappointed in lack of generic update on our 11 drugs
would have been more optimistic if they had some columns with
potential dates,,,,,oh well short term a downer as we wait
art drugs data in oct.
yes, good explanation about isradipine process, but downer
when all is said and done we may get launch in winter months this year....???????????????? so other drugs may get spoken about in
2015? short term might hurt stock
on a lighter note,
guys SALLY! think she would enjoy my company? she thinks/talks/
like me,,,,anyone on this board could introduce us? T.I.A
I would take a bong out and candy dish of oxys, percs, Ativan,
anti depressants etc. and man oh man the subjects we will discuss
is mind boggling....there is so much in this universe to discuss.
snup dawg....overall:
we live or die with the fda, MR.Hakim continues to move the chains
and I continue to have utmost confidence in him....
his back ground, connections, expertise, integrity, will more and
more come into play after rodman conference,
this will provide great leverage as discussions with partners turn
more serious when data is released.
snup loyal long but want to be fair and balanced,
Let's go, bear raid this thing, hit those stop losses on the weak hands ... I'm buying today at .305 and .285
Targiniq: From the company website
http://www.purduepharma.com/news-media/2013/1...blets-cii/
FDA Accepts for Review Purdue Pharma’s New Drug Application for Targiniq™ ER (oxycodone HCl/naloxone HCL Controlled-Release) Tablets CII
Stamford, CT – November 26, 2013 – Purdue Pharma L.P. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for Targiniq™ ER (oxycodone HCl/naloxone HCl controlled-release) Tablets CII, for the management of chronic pain.
“This milestone brings us closer to offering an important treatment option for the management of chronic pain,” said Gary L. Stiles, MD, Purdue Pharma’s Senior Vice President of Research and Development. “It also represents another step forward in our effort to develop an array of products that incorporate abuse-deterrent features.”
This investigational drug combines the opioid analgesic, oxycodone, and the opioid antagonist, naloxone. If approved by the FDA, Targiniq ER would be available in 10/5 mg, 20/10 mg and 40/20 mg dosage strengths for dosing every 12 hours (Q12H).
The NDA is based on the results of a 12-week, double-blind, randomized, placebo-controlled U.S. clinical trial with 600 opioid-experienced patients as well as supporting data from other clinical studies. The submission also includes data from clinical abuse liability studies designed and conducted consistent with FDA’s January 2013 Draft Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling. In the NDA submission, Purdue Pharma is requesting the inclusion of language about abuse deterrence in the product’s proposed label based on the results of these studies.
This product was first approved in Germany in 2006 under the brand name Targin® and is currently marketed in 32 countries, including Canada, the United Kingdom, and Australia under the trade names Targin®, Targiniq®, and Targinact®.
About Chronic Pain
Purdue is a leader in developing treatment options for the management of chronic pain, which is one of the most common reasons for visits to healthcare professionals. Chronic pain conditions affect more than 100 million U.S. adults and costs the American economy as much as $635 billion each year in direct healthcare expenses and lost productivity.
About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.
Contact:
James Heins
Senior Director, Public Affairs
Office: 203-588-8069
Email: james.heins@pharma.com
Interesting- never gave this a thought. When we get eli-200 approved, I would imagine that you can still over dose with the product??
New painkiller created to discourage abuse
Published: Sunday, August 10, 2014
By Rose Quinn
rquinn@21st-centurymedia.com
As Pennsylvania lawmakers continue to mull uses of naloxone, the Food and Drug Administration has approved a new extended-release pill that combines oxycodone with the widely hailed “miracle drug” used to reverse the effects of an overdose of an opiate like heroin.
Targiniq ER, manufactured by Purdue Pharma, is a combination of oxycodone hydrochloride, an opioid agonist, and naloxone hydrochloride, an opioid antagonist, in a 2-to-1 ratio. Purdue Pharma is still in the process of developing commercial plans.
The pill is designed for patients whose pain is severe enough to require daily, around-the-clock, long-term opioid treatment, while alternative treatments — including non-opioids like acetaminophen and ibuprofen or immediate-release opioids like Vicodin or Percocet — were proven inadequate.
“It’s for people who have a certain intensity and duration of pain, and for whom the alternative medications are not viable,” Purdue Pharma’s Senior Director of Public Affairs James W. Heins said of the new painkiller.
“Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting or injecting,” the FDA announced in a July 23 press release. “When crushed and snorted, dissolved or injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone.”
Oxycodone, a Schedule II controlled substance that’s been around since the 1900s, has a high potential for abuse similar to other opioids, including fentanyl, hydromorphone, methadone, morphine and oxymorphone. OxyContin is the trade name for oxycodone hydrochloride. Targiniq ER is the second extended-release, long-lasting opioid analgesic with FDA approval.
According to the FDA, the safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain, and the safety database supporting approval included treatment of more than 3,000 people. The FDA is requiring post-marketing studies to assess the serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks, and to further assess the effects of abuse-deterrent features on the risk for abuse.
Saying he welcomed anything “that could help” the epidemic opioid abuse problem plaguing Delaware County, District Attorney Jack Whelan was quick to note that drug abusers “typically find a way to get around the safeguards.”
George Avetian, D.O., Delaware County senior medical adviser and a member of the Delaware County Heroin Task Force, said he was never a big prescriber of narcotic analgesics in his former family practice, as perhaps an oncologist or an orthopedic surgeon would be. But he believes the new pill has merits, though he is not yet familiar with all its nuances.
“It’s an interesting concept. I guess what they are trying to do is marry the two ingredients in hopes of deterring addiction,” Avetian said. “It is good to have a product to address the needs of a pain sufferer while deterring
Avetian, too, spoke of potential abuse.
“I think what Purdue did was put a product on the market to deter that potential for abuse. Unfortunately, these prescription drugs when they get into the wrong hands or not taken properly are addicting and become a gateway to heroin,” he said.
According to the FDA, Targiniq ER can still be abused, including when taken orally, which is currently the most common way to oxycodone is abuse. And taking too much for purposes of abuse or by accident can cause an overdose that can result in death.
“The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” Sharon Hertiz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said in a prepared release. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach of reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”
Regarding abuse, Purdue Pharma said all patients treated with opioids require careful monitoring for signs of abuse and addiction.
Whelan and other law enforcers throughout Delaware County have repeatedly identified the use of heroin, a highly addictive opioid, as a major problem. And the majority of heroin addicts began with an addiction to prescription opioids such as OxyContin, Vicodin or Percocet.
According to Delaware County officials, there was a 174 percent increase in heroin-related deaths between 2007 and 2013. In 2012, Whelan organized the Delaware County Heroin Task Force to raise awareness about escalating heroin and prescription drug abuse through school and other community education outreach, and to offer life-saving resources. Task force members include parents, health care professionals, educators and service providers.
Tricia Stouch of Aston, whose 19-year-old daughter Pamela died of a heroin overdose in 2010, is a member of both the Delaware County Heroin Task Force and Narcotics Overdose Prevention & Education (N.O.P.E.)
Stouch said she’s been reading up on Targiniq ER, trying to educate herself.
“If it does what they say and it blocks the opiate high, I’m in favor of it,” she said. Continued...
Stouch is also in favor of first-responders carrying Narcan in their vehicles. Narcan is among the various trademarks under which naloxone is marketed.
State Rep. Joseph Hackett, R-161, of Ridley Township, is continuing to push for passage of Senate Bill 1164, which is also known as the Good Samaritan Bill and remains on the House floor, spokeswoman Lauren Contino said last week.
In June, Hackett announced that the state House passed his amendment to the legislation. As is, the bill states that a person who helps someone experiencing a drug overdose shall not be charged or prosecuted if that person cooperates with authorities, under certain conditions. The pending law would not protect those who commit offenses involving delivery or distribution of a controlled substance, or drug-induced homicide. It also includes language involving naloxone.
As the bill was running on the House floor, according to Contino, committee Chairman Gene DiGirolamo, R-18, of Bensalem, amended language to expand those who would be permitted to administer Narcan from police and firefighters to include family and friends.
Training is among the issues under discussion.
As Pennsylvania lawmakers continue to mull uses of naloxone, the Food and Drug Administration has approved a new extended-release pill that combines oxycodone with the widely hailed “miracle drug” used to reverse the effects of an overdose of an opiate like heroin.
Targiniq ER, manufactured by Purdue Pharma, is a combination of oxycodone hydrochloride, an opioid agonist, and naloxone hydrochloride, an opioid antagonist, in a 2-to-1 ratio. Purdue Pharma is still in the process of developing commercial plans.
The pill is designed for patients whose pain is severe enough to require daily, around-the-clock, long-term opioid treatment, while alternative treatments — including non-opioids like acetaminophen and ibuprofen or immediate-release opioids like Vicodin or Percocet — were proven inadequate.
“It’s for people who have a certain intensity and duration of pain, and for whom the alternative medications are not viable,” Purdue Pharma’s Senior Director of Public Affairs James W. Heins said of the new painkiller.
“Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting or injecting,” the FDA announced in a July 23 press release. “When crushed and snorted, dissolved or injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone.”
Oxycodone, a Schedule II controlled substance that’s been around since the 1900s, has a high potential for abuse similar to other opioids, including fentanyl, hydromorphone, methadone, morphine and oxymorphone. OxyContin is the trade name for oxycodone hydrochloride. Targiniq ER is the second extended-release, long-lasting opioid analgesic with FDA approval.
According to the FDA, the safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain, and the safety database supporting approval included treatment of more than 3,000 people. The FDA is requiring post-marketing studies to assess the serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks, and to further assess the effects of abuse-deterrent features on the risk for abuse.
Saying he welcomed anything “that could help” the epidemic opioid abuse problem plaguing Delaware County, District Attorney Jack Whelan was quick to note that drug abusers “typically find a way to get around the safeguards.”
George Avetian, D.O., Delaware County senior medical adviser and a member of the Delaware County Heroin Task Force, said he was never a big prescriber of narcotic analgesics in his former family practice, as perhaps an oncologist or an orthopedic surgeon would be. But he believes the new pill has merits, though he is not yet familiar with all its nuances.
“It’s an interesting concept. I guess what they are trying to do is marry the two ingredients in hopes of deterring addiction,” Avetian said. “It is good to have a product to address the needs of a pain sufferer while deterring addiction and overdose.
Avetian, too, spoke of potential abuse.
“I think what Purdue did was put a product on the market to deter that potential for abuse. Unfortunately, these prescription drugs when they get into the wrong hands or not taken properly are addicting and become a gateway to heroin,” he said.
According to the FDA, Targiniq ER can still be abused, including when taken orally, which is currently the most common way to oxycodone is abuse. And taking too much for purposes of abuse or by accident can cause an overdose that can result in death.
“The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” Sharon Hertiz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said in a prepared release. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach of reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”
Regarding abuse, Purdue Pharma said all patients treated with opioids require careful monitoring for signs of abuse and addiction.
Whelan and other law enforcers throughout Delaware County have repeatedly identified the use of heroin, a highly addictive opioid, as a major problem. And the majority of heroin addicts began with an addiction to prescription opioids such as OxyContin, Vicodin or Percocet.
According to Delaware County officials, there was a 174 percent increase in heroin-related deaths between 2007 and 2013. In 2012, Whelan organized the Delaware County Heroin Task Force to raise awareness about escalating heroin and prescription drug abuse through school and other community education outreach, and to offer life-saving resources. Task force members include parents, health care professionals, educators and service providers.
Tricia Stouch of Aston, whose 19-year-old daughter Pamela died of a heroin overdose in 2010, is a member of both the Delaware County Heroin Task Force and Narcotics Overdose Prevention & Education (N.O.P.E.)
Stouch said she’s been reading up on Targiniq ER, trying to educate herself.
“If it does what they say and it blocks the opiate high, I’m in favor of it,” she said.
Stouch is also in favor of first-responders carrying Narcan in their vehicles. Narcan is among the various trademarks under which naloxone is marketed.
State Rep. Joseph Hackett, R-161, of Ridley Township, is continuing to push for passage of Senate Bill 1164, which is also known as the Good Samaritan Bill and remains on the House floor, spokeswoman Lauren Contino said last week.
In June, Hackett announced that the state House passed his amendment to the legislation. As is, the bill states that a person who helps someone experiencing a drug overdose shall not be charged or prosecuted if that person cooperates with authorities, under certain conditions. The pending law would not protect those who commit offenses involving delivery or distribution of a controlled substance, or drug-induced homicide. It also includes language involving naloxone.
As the bill was running on the House floor, according to Contino, committee Chairman Gene DiGirolamo, R-18, of Bensalem, amended language to expand those who would be permitted to administer Narcan from police and firefighters to include family and friends.
Training is among the issues under discussion.
Link: http://www.mainlinemedianews.com/articles/201...=fullstory
Would be great if that is the case aELm. Between now an early Oct is a while though. Don't think other news than ELI-200 related will be able to move us up substantially.
Patience + dry powder to average down (in my case) is in no short supply!
I will just take the word of the FDA. thNKA
http://www.fda.gov/NewsEvents/Newsroom/PressA...406407.htm
Actually agree 100%.
Fast track from there, GLTA
Holding .31 good support there
lasers, no doubt. we live or die with fda decision
I am left with my observation that regarding generics
they are merely a hobby of elite and seem to be tinkered
puttered around with, as a way to relax from the real work
at hand our art drugs, I get it, but would like to have seen
cash flow positive on generic side of busin. which at one time
would have brought us to 1-2 bucks on their own if serious concern
work hours were thrown to that division
snup dawg
Quote:
I'm buying today at .305 and .285
yeah right...why .305 if you think its going as low as .285 ?
snupoled. The meat on the bone is coming for $ELTP. The planned meeting with the FDA in Sept/Oct is like 110% positive for ELI-200 which will be $ELTP FLAGSHIP first ART/ADT.
thanks Lasers,
I guess I want more meat on the bone concerning "being on track"
with all our generics....
snup
Doug Plassche has done a marvellous job in securing the API for Isradipine. It has been a very difficult process and the supplier of Isradipine wanted to be assured that $ELTP would take the entire batch for Isradipine starting API. The only other seller of Isradipine is Actavis/Watson. Doug Plassche is a leading expert on Isradipine from his employment at Actavis. $ELTP is very blessed to have such a talented VP of Operations Doug Plassche.
Quote:
any disappointment in q-4 launch of isradipine?
None whatsoever! $ELTP is on track with its Generics and ART/ADT ELI drugs
Lasers,
what is your take on generics, what is the timeline on them?
any disappointment in q-4 launch of isradipine?
snup
Well that is good advice- assume that you are going to lose your entire investment before you invest- uh? My plan was to never lose a dime thank you
conix TOTAL NONSENSE! Targiniq ER is a co-drug to relieve OIC (Opioid Induced Constipation) It was thoroughly discussed a few weeks back in several of my posts.
The Naloxone is NOT on standby for abuse deterrence but is CO-RELEASED with the Oxycodone to partially block ONLY the Intestinal mu receptors to prevent OIC!!!!!
John,
with generics I am in agreement, what was said vs.q4 launch is
disappointing, also no time line on other generics makes it feel
like we may be deep into 2015 before they launch..
but,
our Ceo is not hear for what I think he sees as a hobby
the generic side of business, so
We live or die by thumbs up thumbs down scenario
awesome news would be , not paying attention to generics
because there is serious discussions of buy out and company
doesn't want the launches until they take over...
anyways,
plan accordingly, I believe we will be much higher on dec.31 2014
than we are now. why snup, because we will see clearly the outline
of our first product, we will know partner news, and we will have
data,,,,we live or die by fda decisions
snup
snup dawg , good morning board,,
fair and balanced,
I was disappointed in lack of generic update on our 11 drugs
would have been more optimistic if they had some columns with
potential dates,,,,,oh well short term a downer as we wait
art drugs data in oct.
yes, good explanation about isradipine process, but downer
when all is said and done we may get launch in winter months this year....???????????????? so other drugs may get spoken about in
2015? short term might hurt stock
on a lighter note,
guys SALLY! think she would enjoy my company? she thinks/talks/
like me,,,,anyone on this board could introduce us? T.I.A
I would take a bong out and candy dish of oxys, percs, Ativan,
anti depressants etc. and man oh man the subjects we will discuss
is mind boggling....there is so much in this universe to discuss.
snup dawg....overall:
we live or die with the fda, MR.Hakim continues to move the chains
and I continue to have utmost confidence in him....
his back ground, connections, expertise, integrity, will more and
more come into play after rodman conference,
this will provide great leverage as discussions with partners turn
more serious when data is released.
snup loyal long but want to be fair and balanced,
Let's go, bear raid this thing, hit those stop losses on the weak hands ... I'm buying today at .305 and .285
Targiniq: From the company website
http://www.purduepharma.com/news-media/2013/1...blets-cii/
FDA Accepts for Review Purdue Pharma’s New Drug Application for Targiniq™ ER (oxycodone HCl/naloxone HCL Controlled-Release) Tablets CII
Stamford, CT – November 26, 2013 – Purdue Pharma L.P. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for Targiniq™ ER (oxycodone HCl/naloxone HCl controlled-release) Tablets CII, for the management of chronic pain.
“This milestone brings us closer to offering an important treatment option for the management of chronic pain,” said Gary L. Stiles, MD, Purdue Pharma’s Senior Vice President of Research and Development. “It also represents another step forward in our effort to develop an array of products that incorporate abuse-deterrent features.”
This investigational drug combines the opioid analgesic, oxycodone, and the opioid antagonist, naloxone. If approved by the FDA, Targiniq ER would be available in 10/5 mg, 20/10 mg and 40/20 mg dosage strengths for dosing every 12 hours (Q12H).
The NDA is based on the results of a 12-week, double-blind, randomized, placebo-controlled U.S. clinical trial with 600 opioid-experienced patients as well as supporting data from other clinical studies. The submission also includes data from clinical abuse liability studies designed and conducted consistent with FDA’s January 2013 Draft Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling. In the NDA submission, Purdue Pharma is requesting the inclusion of language about abuse deterrence in the product’s proposed label based on the results of these studies.
This product was first approved in Germany in 2006 under the brand name Targin® and is currently marketed in 32 countries, including Canada, the United Kingdom, and Australia under the trade names Targin®, Targiniq®, and Targinact®.
About Chronic Pain
Purdue is a leader in developing treatment options for the management of chronic pain, which is one of the most common reasons for visits to healthcare professionals. Chronic pain conditions affect more than 100 million U.S. adults and costs the American economy as much as $635 billion each year in direct healthcare expenses and lost productivity.
About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.
Contact:
James Heins
Senior Director, Public Affairs
Office: 203-588-8069
Email: james.heins@pharma.com
Interesting- never gave this a thought. When we get eli-200 approved, I would imagine that you can still over dose with the product??
New painkiller created to discourage abuse
Published: Sunday, August 10, 2014
By Rose Quinn
rquinn@21st-centurymedia.com
As Pennsylvania lawmakers continue to mull uses of naloxone, the Food and Drug Administration has approved a new extended-release pill that combines oxycodone with the widely hailed “miracle drug” used to reverse the effects of an overdose of an opiate like heroin.
Targiniq ER, manufactured by Purdue Pharma, is a combination of oxycodone hydrochloride, an opioid agonist, and naloxone hydrochloride, an opioid antagonist, in a 2-to-1 ratio. Purdue Pharma is still in the process of developing commercial plans.
The pill is designed for patients whose pain is severe enough to require daily, around-the-clock, long-term opioid treatment, while alternative treatments — including non-opioids like acetaminophen and ibuprofen or immediate-release opioids like Vicodin or Percocet — were proven inadequate.
“It’s for people who have a certain intensity and duration of pain, and for whom the alternative medications are not viable,” Purdue Pharma’s Senior Director of Public Affairs James W. Heins said of the new painkiller.
“Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting or injecting,” the FDA announced in a July 23 press release. “When crushed and snorted, dissolved or injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone.”
Oxycodone, a Schedule II controlled substance that’s been around since the 1900s, has a high potential for abuse similar to other opioids, including fentanyl, hydromorphone, methadone, morphine and oxymorphone. OxyContin is the trade name for oxycodone hydrochloride. Targiniq ER is the second extended-release, long-lasting opioid analgesic with FDA approval.
According to the FDA, the safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain, and the safety database supporting approval included treatment of more than 3,000 people. The FDA is requiring post-marketing studies to assess the serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks, and to further assess the effects of abuse-deterrent features on the risk for abuse.
Saying he welcomed anything “that could help” the epidemic opioid abuse problem plaguing Delaware County, District Attorney Jack Whelan was quick to note that drug abusers “typically find a way to get around the safeguards.”
George Avetian, D.O., Delaware County senior medical adviser and a member of the Delaware County Heroin Task Force, said he was never a big prescriber of narcotic analgesics in his former family practice, as perhaps an oncologist or an orthopedic surgeon would be. But he believes the new pill has merits, though he is not yet familiar with all its nuances.
“It’s an interesting concept. I guess what they are trying to do is marry the two ingredients in hopes of deterring addiction,” Avetian said. “It is good to have a product to address the needs of a pain sufferer while deterring
Avetian, too, spoke of potential abuse.
“I think what Purdue did was put a product on the market to deter that potential for abuse. Unfortunately, these prescription drugs when they get into the wrong hands or not taken properly are addicting and become a gateway to heroin,” he said.
According to the FDA, Targiniq ER can still be abused, including when taken orally, which is currently the most common way to oxycodone is abuse. And taking too much for purposes of abuse or by accident can cause an overdose that can result in death.
“The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” Sharon Hertiz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said in a prepared release. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach of reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”
Regarding abuse, Purdue Pharma said all patients treated with opioids require careful monitoring for signs of abuse and addiction.
Whelan and other law enforcers throughout Delaware County have repeatedly identified the use of heroin, a highly addictive opioid, as a major problem. And the majority of heroin addicts began with an addiction to prescription opioids such as OxyContin, Vicodin or Percocet.
According to Delaware County officials, there was a 174 percent increase in heroin-related deaths between 2007 and 2013. In 2012, Whelan organized the Delaware County Heroin Task Force to raise awareness about escalating heroin and prescription drug abuse through school and other community education outreach, and to offer life-saving resources. Task force members include parents, health care professionals, educators and service providers.
Tricia Stouch of Aston, whose 19-year-old daughter Pamela died of a heroin overdose in 2010, is a member of both the Delaware County Heroin Task Force and Narcotics Overdose Prevention & Education (N.O.P.E.)
Stouch said she’s been reading up on Targiniq ER, trying to educate herself.
“If it does what they say and it blocks the opiate high, I’m in favor of it,” she said. Continued...
Stouch is also in favor of first-responders carrying Narcan in their vehicles. Narcan is among the various trademarks under which naloxone is marketed.
State Rep. Joseph Hackett, R-161, of Ridley Township, is continuing to push for passage of Senate Bill 1164, which is also known as the Good Samaritan Bill and remains on the House floor, spokeswoman Lauren Contino said last week.
In June, Hackett announced that the state House passed his amendment to the legislation. As is, the bill states that a person who helps someone experiencing a drug overdose shall not be charged or prosecuted if that person cooperates with authorities, under certain conditions. The pending law would not protect those who commit offenses involving delivery or distribution of a controlled substance, or drug-induced homicide. It also includes language involving naloxone.
As the bill was running on the House floor, according to Contino, committee Chairman Gene DiGirolamo, R-18, of Bensalem, amended language to expand those who would be permitted to administer Narcan from police and firefighters to include family and friends.
Training is among the issues under discussion.
As Pennsylvania lawmakers continue to mull uses of naloxone, the Food and Drug Administration has approved a new extended-release pill that combines oxycodone with the widely hailed “miracle drug” used to reverse the effects of an overdose of an opiate like heroin.
Targiniq ER, manufactured by Purdue Pharma, is a combination of oxycodone hydrochloride, an opioid agonist, and naloxone hydrochloride, an opioid antagonist, in a 2-to-1 ratio. Purdue Pharma is still in the process of developing commercial plans.
The pill is designed for patients whose pain is severe enough to require daily, around-the-clock, long-term opioid treatment, while alternative treatments — including non-opioids like acetaminophen and ibuprofen or immediate-release opioids like Vicodin or Percocet — were proven inadequate.
“It’s for people who have a certain intensity and duration of pain, and for whom the alternative medications are not viable,” Purdue Pharma’s Senior Director of Public Affairs James W. Heins said of the new painkiller.
“Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting or injecting,” the FDA announced in a July 23 press release. “When crushed and snorted, dissolved or injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone.”
Oxycodone, a Schedule II controlled substance that’s been around since the 1900s, has a high potential for abuse similar to other opioids, including fentanyl, hydromorphone, methadone, morphine and oxymorphone. OxyContin is the trade name for oxycodone hydrochloride. Targiniq ER is the second extended-release, long-lasting opioid analgesic with FDA approval.
According to the FDA, the safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain, and the safety database supporting approval included treatment of more than 3,000 people. The FDA is requiring post-marketing studies to assess the serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks, and to further assess the effects of abuse-deterrent features on the risk for abuse.
Saying he welcomed anything “that could help” the epidemic opioid abuse problem plaguing Delaware County, District Attorney Jack Whelan was quick to note that drug abusers “typically find a way to get around the safeguards.”
George Avetian, D.O., Delaware County senior medical adviser and a member of the Delaware County Heroin Task Force, said he was never a big prescriber of narcotic analgesics in his former family practice, as perhaps an oncologist or an orthopedic surgeon would be. But he believes the new pill has merits, though he is not yet familiar with all its nuances.
“It’s an interesting concept. I guess what they are trying to do is marry the two ingredients in hopes of deterring addiction,” Avetian said. “It is good to have a product to address the needs of a pain sufferer while deterring addiction and overdose.
Avetian, too, spoke of potential abuse.
“I think what Purdue did was put a product on the market to deter that potential for abuse. Unfortunately, these prescription drugs when they get into the wrong hands or not taken properly are addicting and become a gateway to heroin,” he said.
According to the FDA, Targiniq ER can still be abused, including when taken orally, which is currently the most common way to oxycodone is abuse. And taking too much for purposes of abuse or by accident can cause an overdose that can result in death.
“The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” Sharon Hertiz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, said in a prepared release. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach of reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain.”
Regarding abuse, Purdue Pharma said all patients treated with opioids require careful monitoring for signs of abuse and addiction.
Whelan and other law enforcers throughout Delaware County have repeatedly identified the use of heroin, a highly addictive opioid, as a major problem. And the majority of heroin addicts began with an addiction to prescription opioids such as OxyContin, Vicodin or Percocet.
According to Delaware County officials, there was a 174 percent increase in heroin-related deaths between 2007 and 2013. In 2012, Whelan organized the Delaware County Heroin Task Force to raise awareness about escalating heroin and prescription drug abuse through school and other community education outreach, and to offer life-saving resources. Task force members include parents, health care professionals, educators and service providers.
Tricia Stouch of Aston, whose 19-year-old daughter Pamela died of a heroin overdose in 2010, is a member of both the Delaware County Heroin Task Force and Narcotics Overdose Prevention & Education (N.O.P.E.)
Stouch said she’s been reading up on Targiniq ER, trying to educate herself.
“If it does what they say and it blocks the opiate high, I’m in favor of it,” she said.
Stouch is also in favor of first-responders carrying Narcan in their vehicles. Narcan is among the various trademarks under which naloxone is marketed.
State Rep. Joseph Hackett, R-161, of Ridley Township, is continuing to push for passage of Senate Bill 1164, which is also known as the Good Samaritan Bill and remains on the House floor, spokeswoman Lauren Contino said last week.
In June, Hackett announced that the state House passed his amendment to the legislation. As is, the bill states that a person who helps someone experiencing a drug overdose shall not be charged or prosecuted if that person cooperates with authorities, under certain conditions. The pending law would not protect those who commit offenses involving delivery or distribution of a controlled substance, or drug-induced homicide. It also includes language involving naloxone.
As the bill was running on the House floor, according to Contino, committee Chairman Gene DiGirolamo, R-18, of Bensalem, amended language to expand those who would be permitted to administer Narcan from police and firefighters to include family and friends.
Training is among the issues under discussion.
Link: http://www.mainlinemedianews.com/articles/201...=fullstory
Would be great if that is the case aELm. Between now an early Oct is a while though. Don't think other news than ELI-200 related will be able to move us up substantially.
Patience + dry powder to average down (in my case) is in no short supply!
