Alkermes’ Antipsychotic Clears US FDA Panel Amid Calls For Broader Professional Education Plan

 
• By Sue Sutter
  
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Communication and education on samidorphan’s opioid antagonistic effects should focus on health care providers that prescribe opioids as well as psychiatrists that prescribe olanzapine, advisory committee says in endorsing the safety and efficacy of ALKS 3831.

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Alkermes proposes to market the drug to treat schizophrenia and bipolar disorder in adults. • Source: Shutterstock

A US Food and Drug Administration joint advisory committee endorsed the efficacy and safety of Alkermes plc's combination antipsychotic drug ALKS 3831 (olanzapine/samidorphan) on 9 October but cited the need to ensure that health care providers in different clinical specialties, and not just prescribing psychiatrists, understand the potential risks stemming from the drug’s opioid antagonist component.

The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 11-6 that labeling would be...

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