Indivior's Monthly Injectable Buprenorphine Wins Panel Backing; US FDA May Limit Dosage
Advisory committee votes 18 to 1 for approval of the opioid abuse disorder treatment with restricted distribution; members advise post-market studies, registry.
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Launch targeted for first quarter 2018 at price of $1,580 per monthly dose. Post-market requirements include study of 300 mg dose and use as initial treatment. Indivior also following health outcomes.
The latest drug development news and highlights from our US FDA Performance Tracker.
US FDA approval of Sublocade, the company's once-monthly buprenorphine depot injection, may help Indivior defend its opioid addiction franchise from generics and the competing Alkermes product Vivitrol. But another new rival is expected soon – a once-monthly product from Braeburn.