Is Alkermes’ Schizophrenia Data Enough To Drive Demand?
Alkermes showed that combo pill ALKS 3831 offers a better weight gain profile compared to olanzapine in schizophrenia patients, but analysts differed on whether the benefit would be great enough to drive demand against entrenched generics.
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The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.
Nearly every panelist cited lack of substantial evidence of efficacy in voting against approval of ALKS 5461, a fixed-dose combination of buprenorphine and samidorphan.