Buprenorphine Injectable Opioid Abuse Treatment: Will REMS Prevent Misuse?
US FDA worries Indivior's formulation in prefilled syringes could lead to adverse events if patients obtain direct access; advisory committee to consider if REMS requiring administration by healthcare providers is adequate.
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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.
Advisory committee votes 18 to 1 for approval of the opioid abuse disorder treatment with restricted distribution; members advise post-market studies, registry.
Unlike its potential competitor Indivior, Braeburn didn't submit a proposed REMS for its subcutaneous opioid abuse treatment, but if approved, both buprenorphine candidates will probably end up with similar risk management restrictions.