Tapentadol hydrochloride approved for pain relief
CardioVascular BioTherapeutics, Inc. , announced today that it has dosed the first patient in North America (NA) as part of its ACORD Phase II clinical trial to treat patients with severe coronary heart disease. The ACORD (Angiogenesis for the treatment of CORonary heart Disease) trial will include four randomized, double-blind, placebo-controlled doses in approximately 120
Full Post: CardioVascular BioTherapeutics doses first patient in trial for severe coronary heart disease
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain.
Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.
“This approval offers health care professionals an additional choice for treating moderate to severe acute pain,” said John Jenkins, M.D., director of the office of new drugs in the FDA’s Center for Drug Evaluation and Research.
Tapentadol acts in two ways, opioid (narcotic) and non-opioid. It affects the brain and body primarily by activating opioid receptors in the brain, spinal cord and gastrointestinal tract. In addition, Tapentadol inhibits the reuptake of the brain chemical norepinephrine which possibly has an analgesic effect.
Acute pain is a symptom of many medical conditions and can significantly interfere with a person’s quality of life and general functioning. Opioids are considered safe and effective in selected patients but can cause dependence, abuse, and addiction. All patients treated with opioids require careful monitoring by their health care professional for signs of abuse and addiction, and to determine when opioid analgesics are no longer needed.
The most common side effects from Tapentadol are nausea, dizziness, vomiting, sleepiness, and headaches. The labeling for Tapentadol includes warnings about the risk of respiratory depression; addictive depressive effects on the central nervous system when taken with alcohol, other opioids, or illicit drugs; and abuse potential.
Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD), announced that the U.S. Food and Drug Administration (FDA) approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years
Full Post: FDA approves tapentadol immediate-release tablets for pain in adults
TheraQuest Biosciences, Inc. a development stage pain management company today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (”IND”) application for TQ-1015, its abuse deterrent extended release strong opioid. TQ-1015 is being developed using Securel, TheraQuest’s proprietary abuse deterrent technology. Najib Babul, PharmD, Chief Executive Officer of
Full Post: TheraQuest’s IND for abuse deterrent strong opioid (TQ-1015) accepted by FDA
Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced today that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL (DepoBupivacaine) for prolonged postoperative analgesia. Results from the studies in hemorrhoidectomy and in total knee arthroplasty (TKA) are expected
Full Post: Phase III studies of EXPAREL (DepoBupivacaine) from Pacira complete enrollment
A review of more than 4 million insured patients with private coverage and Medicaid, published in the The Journal of Pain showed that rates of opioid use did not differ widely between non-cancer pain conditions but there were higher rates of opioid use among Medicaid patients. In this study, researchers examined general trends in prescription
Full Post: Researchers examine trends in prescription opioid use for non-cancer pain
Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company’s Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil’s chronic pain treatment Duragesic. Shipment of this product has commenced.
Full Post: Teva granted FDA approval for Fentanyl transdermal system