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Braeburn's Buprenorphine Candidate Faces Safety Gauntlet At US FDA Panel

 
• By Michael Cipriano

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.

Braeburn Pharmaceuticals Inc.'s subcutaneous buprenorphine formulation appears to be in good shape heading into a US FDA advisory panel, although the opioid use disorder (OUD) treatment will likely be subject to similar discussions regarding a Risk Evaluation and Mitigation Strategy (REMS) that Indivior PLCwill face the day before for its own OUD candidate.

FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee will convene in a joint session Nov. 1 to weigh in on Braeburn's CAM 2038 (buprenorphine injectable), one day after the same panel will discuss Indivior's subcutaneous RBP-6000 (buprenorphine injectable)

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