Alkermes submits VIVITROL sNDA for opioid dependence Alkermes.
Alkermes submits VIVITROL sNDA for opioid dependence Alkermes, Inc.S. Meals and Drug Administration for approval as a treatment for opioid dependence pde5 inhibitors . The ongoing company requested important review because of its sNDA and if granted by the FDA, it could mean a six month critique timeline. The sNDA is founded on the excellent results from a recently available phase 3 study assessing the efficacy and protection of VIVITROL for opioid dependence. VIVITROL is an opioid antagonist administered once-regular monthly by intramuscular injection and is definitely accepted in the U.S. For the treatment of alcohol dependence.
The full total results of this phase 2b study, along with those from the dose-ranging, four-week stage 2b study initiated previously this full year, are anticipated to be section of the End-of-Phase 2 submission bundle to the U.S. Food and Drug Administration . Related StoriesInner ear damage mind warnings from nerve cellsFDA accepts Braeburn's resubmission of Probuphine NDA for reviewBraeburn, Camurus announce FDA Fast Monitor designation for CAM2038 to treat opioid addiction’We believe ALKS 37 gets the potential to normalize bowel function in patients getting treated with opioids for chronic discomfort, without affecting their analgesic effects, and we are excited to initiate this phase 2b research of ALKS 37 for OIC,’ said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes.