The FDA approved Opvee nalmefene hydrochloride nasal spray for the emergency treatment of opioid overdoses from Opiant Pharmaceuticals. Approval covers the treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This market the first such authorization for this type of spray in healthcare and community use. […]
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Mylan launches generic sublingual film for opioid dependence
Mylan (NSDQ:MYL) said today that it launched its buprenorphine and naloxone sublingual film as a generic of Indivior‘s (LON:INDV) Suboxone sublingual film. The product is indicated for the treatment of opioid dependence. The therapy should be used alongside counseling and psychosocial support for people living with opioid dependence, according to Mylan. Sales for buprenorphine and naloxone […]
Dr. Reddy’s notches win for generic Suboxone sublingual film
Shares in Dr. Reddy’s Laboratories (NYSE:RDY) shot up yesterday after the U.S. Court of Appeals for the Federal Circuit vacated a previous decision that blocked the company from selling a generic verson of Indivior‘s (LON:INDV) Suboxone buprenorphine and naloxone sublingual film. Dr. Reddy’s said it plans to resume launch activities for the product, which won FDA […]
FDA approves first generic sublingual film to treat opioid addiction
The FDA this week approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan (NSDQ:MYL), is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids. “The FDA […]
FDA approves first once-monthly buprenorphine injection to treat opioid addiction
Indivior (LON:INDV) shares jumped today after the FDA approved its once-monthly buprenorphine injection for the treatment of opioid addiction in adult patients who have started therapy with a transmucosal buprenorphine product. The company’s once-monthly injection is the first medication-assisted treatment option of its kind, the regulatory agency touted. Before Indivior’s Sublocade was approved, all other available […]
Advisory committee backs Indivior’s once-monthly opioid use disorder treatment
Indivior (LON:INDV) said today that the FDA’s psychopharmacologic drugs advisory committee and drug safety and risk management advisory committee voted 18-1 recommending approval of the company’s once-monthly injectable treatment for opioid use disorder. The company’s RBP-6000 treatment is designed for adults with moderate-to-severe opioid use disorder. The FDA is slated to make a decision about Indivior’s […]
FDA grants priority review to Indivior’s monthly buprenorphine depot
Indivior (LON:INDV) said today that the FDA accepted the new drug application for its once-monthly injectable buprenorphine depot as a treatment for adults with opioid use disorder. The regulatory agency also granted priority review designation to the company’s NDA. Indivior’s application was supported by data from a pivotal Phase III trial, which evaluated the safety and efficacy […]
Indivior touts late-stage trial for monthly buprenorphine depot
Indivior (LON:INDV) touted data today from its pivotal Phase III trial for RBP-6000, a once-monthly injectable buprenorphine depot for the treatment of adults with opioid use disorder. The 24-week study met its primary and key secondary endpoints for both dosage regimens, according to the company. “The clinical data from our Phase III study also showed […]
