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Braeburn Gets CRL For CAM2038 In Opioid Use Disorder, Yields Ground To Indivior

 
• By Mandy Jackson

Braeburn was in a position to launch its buprenorphine injection CAM2038 within a month and a half of its Jan. 19 PDUFA date, putting the opioid addiction therapy on the market around the same time as Indivior's Sublocade, but now there may be several months between the products' launches.

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Braeburn Pharmaceuticals Inc. said on Jan. 22 that the US FDA issued a complete response letter (CRL) rejecting CAM2038, a buprenorphine depot injection for the treatment of opioid use disorder (OUD), giving Indivior PLC's Sublocade more time on the market without a direct competitor.

The PDUFA date for CAM2038 was Jan. 19, which came and went without an announcement from Braeburn or the FDA about approval or rejection of the opioid addiction therapy

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