Acelrx Pharmaceutica (ACRX) 3.19 $ACRX
TSRI Appoints Richard King as Chief Operating Officer
PR Newswire - Mon Jun 06, 10:49AM CDT
The Scripps Research Institute (TSRI) has named Richard A. King, formerly president and CEO of AcelRx Pharmaceuticals, Inc., as chief operating officer.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Participate in Three Upcoming Healthcare Investor Events in June
PR Newswire - Thu Jun 02, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Senior Management will be presenting at the Jefferies 2016 Healthcare Conference, 2016 BIO International Convention and participating in the 3rd Annual ROTH Healthcare Day.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Presents Results from Phase 3 Study of ARX--04 following Ambulatory Abdominal Surgeries at Euroanaesthesia
PR Newswire - Thu May 26, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that the Company and its investigators will be presenting Phase 3 SAP301 study results at Euroanaesthesia 2016, which is taking place in London, UK on May 28-30, 2016. In the SAP301 study, patients with moderate-to-severe acute pain following abdominoplasty, hernioplasty or laparoscopic abdominal surgeries were randomized to receive either ARX-04 (sufentanil sublingual 30 mcg tablet) or a placebo sublingual tablet. The study met its primary endpoint with statistically significant pain intensity differences to baseline over the 12-hour study period (SPID12) in favor of ARX-04 (p<0.001). When analyzed by type of surgery, treatment with ARX-04 resulted in a statistically significant benefit over placebo in each surgery type. ARX-04 was well tolerated in the trial, with nausea, headache and vomiting being the most common treatment-emergent adverse events reported.
ACRX: 3.19 (-0.16)
New Study Reveals Cost of Initial IV Opioid Dose in the Emergency Department for the Treatment of Acute Pain Exceeds $140
PR Newswire - Tue May 24, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today reported that the Company will be presenting an evaluation of the cost of delivering IV opioids in the emergency department for the treatment of acute pain. Based on an analysis of over 7 million patients who received IV opioids in 614 US emergency departments, it was found that the cost of administering an initial IV opioid dose ranges from $143 for morphine to $145 for fentanyl. This analysis will be presented at the 21st annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), which is being held May 21-25, 2016 in Washington, DC. The study was sponsored by AcelRx Pharmaceuticals, Inc.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Presents Subgroup Analysis Demonstrating Positive Results of ARX--04 by Type of Abdominal Surgery
PR Newswire - Fri May 06, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that the Company and its investigators will be presenting a subgroup analysis of the Phase 3 SAP301 study results by surgery type (abdominoplasty, hernioplasty and laparoscopic abdominal surgery). SAP301 was a Phase 3 trial comparing ARX-04 (sufentanil sublingual 30 mcg tablet) to a placebo sublingual tablet in 163 patients with moderate-to-severe acute pain following ambulatory abdominal surgery. The analysis will be presented at the Society for Ambulatory Anesthesia (SAMBA) 31st Annual Meeting, which is being held May 5-7, 2016 in Orlando, FL.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Present at Two Upcoming Investor Events in May
PR Newswire - Wed May 04, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Senior Management will be presenting at BioEquity Europe Conference 2016 and Bank of America Merrill Lynch 2016 Health Care Conference.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Provides Corporate Update and Reports First Quarter 2016 Financial Results
PR Newswire - Mon May 02, 3:01PM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today provided a business update and reported financial results for the three months ended March 31, 2016.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Hold First Quarter Financial Results Conference Call and Webcast on Monday, May 2nd, 2016
PR Newswire - Thu Apr 28, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain today announced that it will release First Quarter financial results after market close on Monday, May 2nd, 2016. AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on May 2nd, 2016 to discuss the financial results and provide a corporate update.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Names Howard B. Rosen as Chief Executive Officer and Provides Update on Clinical Development Activities and Corporate Priorities for 2016
PR Newswire - Tue Mar 29, 3:00PM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced today the appointment of Howard B. Rosen as the Chief Executive Officer of AcelRx, effective April 1, 2016. Mr. Rosen has served as the interim CEO for AcelRx since April 1, 2015. Mr. Rosen is an experienced and technically trained executive with over 25 years of success growing start-up and mid-size biopharmaceutical companies. Mr. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development, and research and development at Gilead Sciences, Inc. and ALZA Corporation. More recently he was interim CEO of Pearl Therapeutics which was subsequently acquired by Astra Zeneca for up to $1.15 billion in 2013. Mr. Rosen has served on the Board of Directors of AcelRx since 2008 and currently serves on the Board of Directors of Alcobra, Ltd. and two private biopharmaceutical companies.
ACRX: 3.19 (-0.16), GILD: 84.45 (-1.32), ADHD: 5.10 (-0.13)
AcelRx Publishes a Review of Hospital-Based Opioid Patient-Controlled Analgesia, Risks and Pharmacoeconomics
PR Newswire - Fri Mar 25, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, reported that a review article entitled "Evolution of Patient-Controlled Analgesia: From Intravenous to Sublingual Treatment" has been published in the peer-reviewed journal, Hospital Pharmacy. This article provides insights into patient-controlled analgesia (PCA) systems, the choice of opioid, risks, and costs associated with PCA usage in U.S. hospitals. Beyond intravenous (IV) PCA, the article also discusses noninvasive options in development, such as the transdermal, inhaled, oral and sublingual delivery of opioids. Zalviso(TM) (sufentanil sublingual tablet system) is profiled as a novel sublingual PCA system in development, and the entirety of the clinical program is reviewed.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Advances ARX-04 into Extension Phase of Open-Label Phase 3 Emergency Room Study
PR Newswire - Mon Mar 14, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced the initiation of the extension phase of the SAP302 study of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury. This ongoing open-label Phase 3 study has completed the initial phase, enrolling 40 patients who each received a single dose of ARX-04. In this extension phase, up to an additional 100 patients may be enrolled, each of whom may receive multiple doses of ARX-04, given hourly as needed for pain, for up to 4 doses. The primary endpoint of SAP302 is the time-weighted summed pain intensity difference to baseline over one hour, or SPID-1.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2015 Financial Results
PR Newswire - Mon Mar 07, 3:01PM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today provided a business update and reported financial results for the three and twelve months ended December 31, 2015.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Hold Annual 2015 Financial Results Conference Call and Webcast on Monday, March 7th, 2016.
PR Newswire - Thu Mar 03, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that it will release fourth quarter and yearly 2015 financial results after market close on Monday, March 7th, 2016. AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on March 7th, 2016 to discuss the financial results and provide a corporate update.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Present at Two Upcoming Investor Events in February
PR Newswire - Wed Feb 03, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Chief Financial Officer and Head of Business Development, Timothy E. Morris will be presenting at the 18th Annual BIO CEO & Investor Conference and the 2016 RBC Capital Markets' Healthcare Conference in New York. Details of the conferences are as follows:
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Announces Presentation of Phase 3 Sufentanil Sublingual 30 mcg Tablet (ARX-04) Data at the European Congress of Ambulatory Surgery
PR Newswire - Thu Jan 21, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that a presentation will be made at the annual European Congress of Ambulatory Surgery to be held January 28th and 29th, 2016 at the Disneyland Hotel New York Convention Centre in Paris, France. This bilingual congress (simultaneous translation will be provided) is co-organized by AFCA (French Association for Ambulatory Surgery) and the IAAS (International Association for Ambulatory Surgery) and will bring together over 800 ambulatory surgery stakeholders from Europe, Asia and North America.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Announces Anticipated 2016 Milestones
PR Newswire - Sun Jan 10, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced anticipated 2016 milestones for its product portfolio, including ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso(TM) (sufentanil sublingual tablet system, 15 mcg). Specifically, AcelRx's corporate goals in the upcoming year are as follows:
ACRX: 3.19 (-0.16)
AcelRx Completes Protocol Review with FDA and Plans to Initiate Phase 3 Open-Label Study (IAP312) for Zalviso(TM) in 1Q 2016
PR Newswire - Fri Jan 08, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today reported that the Company has received comments from the Division of Anesthesia, Analgesia, and Addiction Products (Division) of the U.S. Food and Drug Administration (FDA) on the Company's proposed protocol for a Phase 3 clinical study (IAP312) designed to assess the overall performance of Zalviso(TM)(sufentanil sublingual tablet system). In response to the comments, the protocol has been amended and AcelRx plans to initiate the study in the first quarter of 2016. The IAP312 study will include approximately 310 post-operative patients and collect information requested by the Division to supplement the three positive Phase 3 trials already completed. Zalviso is being developed for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
ACRX: 3.19 (-0.16)
Global Acute Pain Therapeutics Pipeline Review, H2 2015
M2 - Thu Jan 07, 10:44AM CST
Research and Markets (http://www.researchandmarkets.com/research/k9flzp/acute_pain) has announced the addition of the "Acute Pain - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Acute Pain, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Acute Pain and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Key Topics Covered: - Introduction - Acute Pain Overview - Therapeutics Development - Pipeline Products for Acute Pain - Overview - Pipeline Products for Acute Pain - Comparative Analysis - Acute Pain - Therapeutics under Development by Companies - Acute Pain - Therapeutics under Investigation by Universities/Institutes - Acute Pain - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Acute Pain - Products under Development by Companies - Acute Pain - Products under Investigation by Universities/Institutes - Acute Pain - Companies Involved in Therapeutics Development - A. Menarini Industrie Farmaceutiche Riunite Srl - AcelRx Pharmaceuticals, Inc. - Adynxx, Inc. - Amorsa Therapeutics Inc. - AnaBios Corporation - Anavex Life Sciences Corp. - AngioChem Inc. - Antibe Therapeutics, Inc. - AskAt Inc. - Cara Therapeutics, Inc. - Centrexion Corporation - Charleston Laboratories, Inc. - ChironWells GmbH - Cytogel Pharma, LLC - Dompe Farmaceutici S.p.A. - Grunenthal GmbH - INSYS Therapeutics, Inc. - Iroko Pharmaceuticals, LLC - KemPharm, Inc. - Kineta, Inc. - Laboratorios Del Dr. Esteve S.A. - Mallinckrodt Plc - MEDRx Co., Ltd. - Nanomerics Ltd - Nektar Therapeutics - Nuvo Research Inc. - Orbis Biosciences, Inc. - Orexo AB - Orion Oyj - Pacira Pharmaceuticals, Inc. - Phosphagenics Limited - Recro Pharma, Inc. - Shulov Innovative Science Ltd. - Sigma-Tau S.p.A. - Syntrix Biosystems, Inc. For more information visit http://www.researchandmarkets.com/research/k9flzp/acute_pain
ACRX: 3.19 (-0.16), KMPH: 6.65 (-0.50), NKTR: 15.80 (-0.48), INSY: 13.99 (-2.04), AVXL: 4.21 (-0.23), PCRX: 44.07 (-1.34), REPH: 8.27 (-0.20), PTIE: 2.19 (-0.02)
AcelRx Pharmaceuticals Receives Notice of Eligibility for Centralized Review of ARX-04 from European Medicines Agency
PR Newswire - Wed Dec 23, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure. ARX-04 (sufentanil sublingual tablet, 30 mcg) is being developed for the treatment of moderate-to-severe acute pain in adult patients administered by a healthcare professional in a medically supervised setting.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Conducts Pre-NDA Meeting with U.S. Food and Drug Administration for ARX-04
PR Newswire - Mon Dec 14, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies designed for the treatment of acute pain, today reported on the outcome of the ARX-04 (sufentanil sublingual tablet, 30 mcg) pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA). The Company intends to pursue an ARX-04 indication for moderate-to-severe pain in a medically supervised setting. To support this indication, based on feedback from the FDA, the Company will expand the clinical program by approximately 165 patients to include individuals from specific populations and settings. Enrollment in the ongoing SAP302 open-label study in the emergency room will be increased, and a new study known as SAP303 is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe pain. SAP303 will focus on enrolling patients greater than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. With these modifications, assuming successful completion of the studies, AcelRx anticipates submitting the NDA for ARX-04 in the second half of 2016
ACRX: 3.19 (-0.16)
TSRI Appoints Richard King as Chief Operating Officer
PR Newswire - Mon Jun 06, 10:49AM CDT
The Scripps Research Institute (TSRI) has named Richard A. King, formerly president and CEO of AcelRx Pharmaceuticals, Inc., as chief operating officer.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Participate in Three Upcoming Healthcare Investor Events in June
PR Newswire - Thu Jun 02, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Senior Management will be presenting at the Jefferies 2016 Healthcare Conference, 2016 BIO International Convention and participating in the 3rd Annual ROTH Healthcare Day.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Presents Results from Phase 3 Study of ARX--04 following Ambulatory Abdominal Surgeries at Euroanaesthesia
PR Newswire - Thu May 26, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that the Company and its investigators will be presenting Phase 3 SAP301 study results at Euroanaesthesia 2016, which is taking place in London, UK on May 28-30, 2016. In the SAP301 study, patients with moderate-to-severe acute pain following abdominoplasty, hernioplasty or laparoscopic abdominal surgeries were randomized to receive either ARX-04 (sufentanil sublingual 30 mcg tablet) or a placebo sublingual tablet. The study met its primary endpoint with statistically significant pain intensity differences to baseline over the 12-hour study period (SPID12) in favor of ARX-04 (p<0.001). When analyzed by type of surgery, treatment with ARX-04 resulted in a statistically significant benefit over placebo in each surgery type. ARX-04 was well tolerated in the trial, with nausea, headache and vomiting being the most common treatment-emergent adverse events reported.
ACRX: 3.19 (-0.16)
New Study Reveals Cost of Initial IV Opioid Dose in the Emergency Department for the Treatment of Acute Pain Exceeds $140
PR Newswire - Tue May 24, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today reported that the Company will be presenting an evaluation of the cost of delivering IV opioids in the emergency department for the treatment of acute pain. Based on an analysis of over 7 million patients who received IV opioids in 614 US emergency departments, it was found that the cost of administering an initial IV opioid dose ranges from $143 for morphine to $145 for fentanyl. This analysis will be presented at the 21st annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), which is being held May 21-25, 2016 in Washington, DC. The study was sponsored by AcelRx Pharmaceuticals, Inc.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Presents Subgroup Analysis Demonstrating Positive Results of ARX--04 by Type of Abdominal Surgery
PR Newswire - Fri May 06, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that the Company and its investigators will be presenting a subgroup analysis of the Phase 3 SAP301 study results by surgery type (abdominoplasty, hernioplasty and laparoscopic abdominal surgery). SAP301 was a Phase 3 trial comparing ARX-04 (sufentanil sublingual 30 mcg tablet) to a placebo sublingual tablet in 163 patients with moderate-to-severe acute pain following ambulatory abdominal surgery. The analysis will be presented at the Society for Ambulatory Anesthesia (SAMBA) 31st Annual Meeting, which is being held May 5-7, 2016 in Orlando, FL.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Present at Two Upcoming Investor Events in May
PR Newswire - Wed May 04, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Senior Management will be presenting at BioEquity Europe Conference 2016 and Bank of America Merrill Lynch 2016 Health Care Conference.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Provides Corporate Update and Reports First Quarter 2016 Financial Results
PR Newswire - Mon May 02, 3:01PM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today provided a business update and reported financial results for the three months ended March 31, 2016.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Hold First Quarter Financial Results Conference Call and Webcast on Monday, May 2nd, 2016
PR Newswire - Thu Apr 28, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain today announced that it will release First Quarter financial results after market close on Monday, May 2nd, 2016. AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on May 2nd, 2016 to discuss the financial results and provide a corporate update.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Names Howard B. Rosen as Chief Executive Officer and Provides Update on Clinical Development Activities and Corporate Priorities for 2016
PR Newswire - Tue Mar 29, 3:00PM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced today the appointment of Howard B. Rosen as the Chief Executive Officer of AcelRx, effective April 1, 2016. Mr. Rosen has served as the interim CEO for AcelRx since April 1, 2015. Mr. Rosen is an experienced and technically trained executive with over 25 years of success growing start-up and mid-size biopharmaceutical companies. Mr. Rosen previously held senior-level general management positions and functional roles in strategy, marketing, finance, business development, and research and development at Gilead Sciences, Inc. and ALZA Corporation. More recently he was interim CEO of Pearl Therapeutics which was subsequently acquired by Astra Zeneca for up to $1.15 billion in 2013. Mr. Rosen has served on the Board of Directors of AcelRx since 2008 and currently serves on the Board of Directors of Alcobra, Ltd. and two private biopharmaceutical companies.
ACRX: 3.19 (-0.16), GILD: 84.45 (-1.32), ADHD: 5.10 (-0.13)
AcelRx Publishes a Review of Hospital-Based Opioid Patient-Controlled Analgesia, Risks and Pharmacoeconomics
PR Newswire - Fri Mar 25, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, reported that a review article entitled "Evolution of Patient-Controlled Analgesia: From Intravenous to Sublingual Treatment" has been published in the peer-reviewed journal, Hospital Pharmacy. This article provides insights into patient-controlled analgesia (PCA) systems, the choice of opioid, risks, and costs associated with PCA usage in U.S. hospitals. Beyond intravenous (IV) PCA, the article also discusses noninvasive options in development, such as the transdermal, inhaled, oral and sublingual delivery of opioids. Zalviso(TM) (sufentanil sublingual tablet system) is profiled as a novel sublingual PCA system in development, and the entirety of the clinical program is reviewed.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Advances ARX-04 into Extension Phase of Open-Label Phase 3 Emergency Room Study
PR Newswire - Mon Mar 14, 6:00AM CDT
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, announced the initiation of the extension phase of the SAP302 study of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury. This ongoing open-label Phase 3 study has completed the initial phase, enrolling 40 patients who each received a single dose of ARX-04. In this extension phase, up to an additional 100 patients may be enrolled, each of whom may receive multiple doses of ARX-04, given hourly as needed for pain, for up to 4 doses. The primary endpoint of SAP302 is the time-weighted summed pain intensity difference to baseline over one hour, or SPID-1.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2015 Financial Results
PR Newswire - Mon Mar 07, 3:01PM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today provided a business update and reported financial results for the three and twelve months ended December 31, 2015.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Hold Annual 2015 Financial Results Conference Call and Webcast on Monday, March 7th, 2016.
PR Newswire - Thu Mar 03, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that it will release fourth quarter and yearly 2015 financial results after market close on Monday, March 7th, 2016. AcelRx management will host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on March 7th, 2016 to discuss the financial results and provide a corporate update.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals to Present at Two Upcoming Investor Events in February
PR Newswire - Wed Feb 03, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that Chief Financial Officer and Head of Business Development, Timothy E. Morris will be presenting at the 18th Annual BIO CEO & Investor Conference and the 2016 RBC Capital Markets' Healthcare Conference in New York. Details of the conferences are as follows:
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Announces Presentation of Phase 3 Sufentanil Sublingual 30 mcg Tablet (ARX-04) Data at the European Congress of Ambulatory Surgery
PR Newswire - Thu Jan 21, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that a presentation will be made at the annual European Congress of Ambulatory Surgery to be held January 28th and 29th, 2016 at the Disneyland Hotel New York Convention Centre in Paris, France. This bilingual congress (simultaneous translation will be provided) is co-organized by AFCA (French Association for Ambulatory Surgery) and the IAAS (International Association for Ambulatory Surgery) and will bring together over 800 ambulatory surgery stakeholders from Europe, Asia and North America.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Announces Anticipated 2016 Milestones
PR Newswire - Sun Jan 10, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced anticipated 2016 milestones for its product portfolio, including ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso(TM) (sufentanil sublingual tablet system, 15 mcg). Specifically, AcelRx's corporate goals in the upcoming year are as follows:
ACRX: 3.19 (-0.16)
AcelRx Completes Protocol Review with FDA and Plans to Initiate Phase 3 Open-Label Study (IAP312) for Zalviso(TM) in 1Q 2016
PR Newswire - Fri Jan 08, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today reported that the Company has received comments from the Division of Anesthesia, Analgesia, and Addiction Products (Division) of the U.S. Food and Drug Administration (FDA) on the Company's proposed protocol for a Phase 3 clinical study (IAP312) designed to assess the overall performance of Zalviso(TM)(sufentanil sublingual tablet system). In response to the comments, the protocol has been amended and AcelRx plans to initiate the study in the first quarter of 2016. The IAP312 study will include approximately 310 post-operative patients and collect information requested by the Division to supplement the three positive Phase 3 trials already completed. Zalviso is being developed for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
ACRX: 3.19 (-0.16)
Global Acute Pain Therapeutics Pipeline Review, H2 2015
M2 - Thu Jan 07, 10:44AM CST
Research and Markets (http://www.researchandmarkets.com/research/k9flzp/acute_pain) has announced the addition of the "Acute Pain - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Acute Pain, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Acute Pain and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Key Topics Covered: - Introduction - Acute Pain Overview - Therapeutics Development - Pipeline Products for Acute Pain - Overview - Pipeline Products for Acute Pain - Comparative Analysis - Acute Pain - Therapeutics under Development by Companies - Acute Pain - Therapeutics under Investigation by Universities/Institutes - Acute Pain - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Acute Pain - Products under Development by Companies - Acute Pain - Products under Investigation by Universities/Institutes - Acute Pain - Companies Involved in Therapeutics Development - A. Menarini Industrie Farmaceutiche Riunite Srl - AcelRx Pharmaceuticals, Inc. - Adynxx, Inc. - Amorsa Therapeutics Inc. - AnaBios Corporation - Anavex Life Sciences Corp. - AngioChem Inc. - Antibe Therapeutics, Inc. - AskAt Inc. - Cara Therapeutics, Inc. - Centrexion Corporation - Charleston Laboratories, Inc. - ChironWells GmbH - Cytogel Pharma, LLC - Dompe Farmaceutici S.p.A. - Grunenthal GmbH - INSYS Therapeutics, Inc. - Iroko Pharmaceuticals, LLC - KemPharm, Inc. - Kineta, Inc. - Laboratorios Del Dr. Esteve S.A. - Mallinckrodt Plc - MEDRx Co., Ltd. - Nanomerics Ltd - Nektar Therapeutics - Nuvo Research Inc. - Orbis Biosciences, Inc. - Orexo AB - Orion Oyj - Pacira Pharmaceuticals, Inc. - Phosphagenics Limited - Recro Pharma, Inc. - Shulov Innovative Science Ltd. - Sigma-Tau S.p.A. - Syntrix Biosystems, Inc. For more information visit http://www.researchandmarkets.com/research/k9flzp/acute_pain
ACRX: 3.19 (-0.16), KMPH: 6.65 (-0.50), NKTR: 15.80 (-0.48), INSY: 13.99 (-2.04), AVXL: 4.21 (-0.23), PCRX: 44.07 (-1.34), REPH: 8.27 (-0.20), PTIE: 2.19 (-0.02)
AcelRx Pharmaceuticals Receives Notice of Eligibility for Centralized Review of ARX-04 from European Medicines Agency
PR Newswire - Wed Dec 23, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, reported that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has confirmed that a Marketing Authorization Application (MAA) for ARX-04 may be submitted in the European Union (EU) under the Agency's centralized procedure. ARX-04 (sufentanil sublingual tablet, 30 mcg) is being developed for the treatment of moderate-to-severe acute pain in adult patients administered by a healthcare professional in a medically supervised setting.
ACRX: 3.19 (-0.16)
AcelRx Pharmaceuticals Conducts Pre-NDA Meeting with U.S. Food and Drug Administration for ARX-04
PR Newswire - Mon Dec 14, 6:00AM CST
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies designed for the treatment of acute pain, today reported on the outcome of the ARX-04 (sufentanil sublingual tablet, 30 mcg) pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA). The Company intends to pursue an ARX-04 indication for moderate-to-severe pain in a medically supervised setting. To support this indication, based on feedback from the FDA, the Company will expand the clinical program by approximately 165 patients to include individuals from specific populations and settings. Enrollment in the ongoing SAP302 open-label study in the emergency room will be increased, and a new study known as SAP303 is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe pain. SAP303 will focus on enrolling patients greater than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. With these modifications, assuming successful completion of the studies, AcelRx anticipates submitting the NDA for ARX-04 in the second half of 2016
ACRX: 3.19 (-0.16)
