Latest Tapentadol Stories

Primary Endpoint achieved as required for United States Food and Drug Administration (FDA) submission BEDMINSTER, N.J. and SYDNEY, April 14 /PRNewswire-FirstCall/ -- QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today the successful completion of the first of two pivotal Phase 3 studies for MoxDuo(®)IR, an immediate-release Dual-Opioid(TM) pain therapy. Required for FDA New Drug Application (NDA) submission, this combination rule study -- comparing the efficacy and safety profiles of...

SAN DIEGO, April 5 /PRNewswire/ -- Tioga Pharmaceuticals, Inc. announced today that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on Special Protocol Assessments (SPAs) for the Phase 3 efficacy protocols for its product candidate, asimadoline, for the treatment of patients with diarrhea-predominant irritable bowel syndrome (D-IBS). The SPAs represent agreement with FDA on the design, execution and analysis of the two planned Phase 3 trials required for...

WALTHAM, Mass., March 31 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, through 2018, the launches and uptake of reformulations of conventional analgesics will drive annual three percent growth in the acute pain drug market in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. The Pharmacor 2010 findings from the topic entitled Acute Pain reveal that, aside from...

DENVER, March 15 /PRNewswire/ -- Forensic Laboratories, a Denver-based laboratory specializing in toxicology services for drug abuse, has unveiled the first oral fluid test for Tapentadol, a new federally approved drug prescribed by doctors for pain management. Previously, laboratories could only detect the drug through urine using liquid chromatography-mass spectrometry-mass spectrometry (LC/MS/MS) technology. Tapentadol, approved by the FDA in late 2008, is considered a narcotic pain...

PHOENIX, March 9 /PRNewswire/ -- INSYS Therapeutics, Inc. announces positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain. All primary and secondary endpoints were achieved in the study, and the drug is the first product to ever show statistically significant pain relief when measuring the summary of pain intensity difference at five minutes (SPID(5)) in a phase III...

Evaluate Analgesic Efficacy and Safety of MoxDuo(TM)IR in Patients with Moderate to Severe Post-Operative Pain Following Total Knee Replacement Surgery SYDNEY and BEDMINSTER, N.J., Feb. 10 /PRNewswire/ -- QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today initiation of its second pivotal Phase 3 registration trial (Study 009) to evaluate analgesic efficacy and safety of MoxDuo(TM)IR, a patented 3:2 ratio fixed dose combination of morphine plus oxycodone. This two-arm study will...

SHELTON, Conn., Feb. 8 /PRNewswire/ -- Cara Therapeutics, Inc. today announced positive data in a Phase II proof-of-concept clinical trial of its peripherally-restricted kappa opioid agonist, CR845. The 46 patient Phase II, multi-center, double-blind, placebo-controlled study was conducted at eight hospitals in the United States and evaluated the efficacy and safety of CR845 in women following laparoscopic-assisted hysterectomy. Subjects were administered a single intravenous infusion of...

SAN ANTONIO, Feb. 4 /PRNewswire/ -- Data from three important studies on tapentadol extended release (ER) tablets, an investigational oral analgesic for the management of moderate to severe chronic pain in patients 18 years of age or older, will be discussed during the poster sessions of the 26th Annual Meeting of the American Academy of Pain Medicine (AAPM), February 3-6, 2010 in San Antonio, TX. Following are details about the presentations, which are supported by Johnson & Johnson...

PHOENIX, Jan. 25 /PRNewswire/ -- INSYS Therapeutics, Inc. announced today the successful completion of the Phase III efficacy clinical trial for its fentanyl sublingual spray product candidate. The product is being developed for the treatment of breakthrough cancer pain (BTCP) in opioid-tolerant cancer patients and the Phase III clinical trial was a multi-center, randomized, double-blind, placebo-controlled study. Dose levels of 100 - 1600 mcg were tested in the trial. In the double-blind...

NASHVILLE, Tenn., Jan. 20 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) has donated 15,000 vials of Caldolor® (ibuprofen) Injection, an intravenous form of ibuprofen, to Haitian relief effort. Caldolor is the first and only injectable product approved for the treatment of pain and reduction of fever in the United States. As health conditions in Haiti continue to deteriorate, Caldolor is expected to help those suffering from fever as a result of disease or...