Alkermes' Depression Drug Likely Needs Another Trial After Crushing US Advisory Cmte. Vote
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.
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ALKS 3831, which combines olanzapine with the mu opioid receptor antagonist samidorphan, was associated with less weight gain compared to olanzapine alone but showed no benefit on metabolic parameters; in advisory committee briefing documents, agency raises theoretical safety concerns about drug’s opioid antagonistic effects in real-world settings.
The latest drug development news and highlights from our US FDA Performance Tracker.
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.