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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