Braeburn's Buprenorphine Candidate Faces Safety Gauntlet At US FDA Panel
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.
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With an FDA decision on its buprenorphine injection expected by Jan. 19, Scrip spoke with Braeburn executives at J.P. Morgan about the company's justification for four once-weekly and four once-monthly doses, competition in the opioid use disorder (OUD) market and the need for more OUD therapies.
Seventeen of the panelists voted that the clinical data support approval for some of Braeburns proposed doses, but no one supported the highest proposed monthly dose.
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.