I'm a bit slow...news! Trials did start and they are waiting on the results from the Dec. 5th trial. The second trial is for 52 people!!!! What could that be???? Fun times at ELTP...
Elite Pharmaceuticals Initiates Pivotal Bioequivalence Study for Second Opioid Abuse Deterrent Product 01/14 01:21 PM
NORTHVALE, N.J., Jan. 14, 2014 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (ELTP:$0.187,0$0.0122,6.98%) ("Elite" or the "Company") ("Elite") (ELTP:$0.187,0$0.0122,6.98%) announced today the first dosing of a pivotal bioequivalence study in healthy volunteers for an undisclosed opioid abuse deterrent product utilizing Elite's proprietary pharmacological abuse deterrent technology.
The study is a single- dose , open-label, partially randomized, three-way crossover study in which 52 healthy adult subjects will receive treatment in a partially randomized sequence. The primary objective of this study is to compare the bioavailability of the Company's abuse deterrent product to that from the reference listed drug under fasted and fed conditions. The secondary objectives are: (i) determine whether or not subjects receiving the Company's formulation are exposed to naltrexone; (ii) evaluate the safety and tolerability of the Company's product.
"Abuse of prescription narcotics is a serious problem in our society and we believe that our pharmacological approach provides a higher barrier to abuse than a physical approach," said Nasrat Hakim, President and CEO of Elite. "We are pleased to announce initiation of this pivotal study for this undisclosed proprietary opioid abuse deterrent product. The dosing of our pilot study for our extended release oxycodone product has also been completed and we await final results from that study."
The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
About Section 505(b)(2)
The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.
About Camargo Pharmaceutical Services
Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.
About Elite's Abuse Deterrent Technology
Elite's abuse deterrent products utilize the Company's proprietary pharmacological abuse deterrent technology. Elite's abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
Elite Pharmaceuticals Initiates Pivotal Bioequivalence Study for Second Opioid Abuse Deterrent Product 01/14 01:21 PM
NORTHVALE, N.J., Jan. 14, 2014 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (ELTP:$0.187,0$0.0122,6.98%) ("Elite" or the "Company") ("Elite") (ELTP:$0.187,0$0.0122,6.98%) announced today the first dosing of a pivotal bioequivalence study in healthy volunteers for an undisclosed opioid abuse deterrent product utilizing Elite's proprietary pharmacological abuse deterrent technology.
The study is a single- dose , open-label, partially randomized, three-way crossover study in which 52 healthy adult subjects will receive treatment in a partially randomized sequence. The primary objective of this study is to compare the bioavailability of the Company's abuse deterrent product to that from the reference listed drug under fasted and fed conditions. The secondary objectives are: (i) determine whether or not subjects receiving the Company's formulation are exposed to naltrexone; (ii) evaluate the safety and tolerability of the Company's product.
"Abuse of prescription narcotics is a serious problem in our society and we believe that our pharmacological approach provides a higher barrier to abuse than a physical approach," said Nasrat Hakim, President and CEO of Elite. "We are pleased to announce initiation of this pivotal study for this undisclosed proprietary opioid abuse deterrent product. The dosing of our pilot study for our extended release oxycodone product has also been completed and we await final results from that study."
The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
About Section 505(b)(2)
The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.
About Camargo Pharmaceutical Services
Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.
About Elite's Abuse Deterrent Technology
Elite's abuse deterrent products utilize the Company's proprietary pharmacological abuse deterrent technology. Elite's abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
