Trials & Filings

BDSI Files Bunavail NDA

FDA accepts application for opioid dependence treatment

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

BioDelivery Sciences International (BDSI) has successfully filed an NDA with the FDA for Bunavail (buprenorphine naloxone buccal film) for the maintenance treatment of opioid dependence Based on timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the Bunavail NDA is expected to be completed by early June 2014. Bunavail utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) technology to deliver buprenorphine for the maintenance treatment of opioid depen...

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