FDA slaps down Braeburn on opioid addiction drug, putting Indivior and Alkermes in strong position
One of the frontrunners in the rush to get new opioid addiction treatments to the market has just hit a roadblock. Just days before its PDUFA date, Braeburn Pharmaceuticals got a complete response letter from the FDA in lieu of an approval.
The company is developing a formulation of buprenorphine that’s injected weekly and monthly. The drug is called CAM2038, and it previously got fast track and priority review designations from the FDA. On the promise of this program, Braeburn just closed a $110 million mezzanine round earlier this month with backers including Deerfield and RA Capital Management.
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