Alk­er­mes like­ly head­ed for ap­proval af­ter ad­comm waves through schiz­o­phre­nia and bipo­lar pro­gram

Alk­er­mes may fi­nal­ly be on the verge of an ap­proval in the psy­chi­atric field a lit­tle less than two years af­ter the FDA re­ject­ed its drug for de­pres­sion.

In a joint ad­comm Fri­day, PDAC and DSR­MAC met to dis­cuss whether the opi­oid an­tag­o­nist por­tion of Alk­er­mes’ ALKS-3831 helped pre­vent weight gain in adults with schiz­o­phre­nia and bipo­lar I dis­or­der. Across three votes, the ad­comm in­di­cat­ed broad sup­port for the ex­per­i­men­tal drug, in­clud­ing a 16-1 tal­ly agree­ing that the can­di­date mean­ing­ful­ly mit­i­gates weight-gain risk.

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