Braeburn's Buprenorphine Clears Advisory Committee, But US FDA Likely To Limit Dosage

 
• By Michael Cipriano

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.

FDA Advisory Committee Feature image

Braeburn Pharmaceuticals Inc.'s subcutaneous buprenorphine candidate CAM2038 seems headed toward a US FDA approval, although the agency will likely limit the dosages provided by the drugmaker.

There were no members at the Nov. 1 joint meeting of the Psychopharmacologic Drugs Advisory Committee and Drug Safety and...

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