Alkermes’ Antipsychotic Combo Faces US FDA Questions On Metabolic Effects, Opioid-Related Safety

 
• By Sue Sutter
  
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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.

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ALKS 3831 resulted in less weight gain compared to use of olanzapine alone. • Source: Shutterstock

The US Food and Drug Administration will ask its external experts to consider whether the olanzapine-related weight gain mitigated with Alkermes plc’s antipsychotic ALKS 3831 (olanzapine/samidorphan) is clinically meaningful, and whether the potential real-world risks associated with the drug’s opioid antagonist component can be addressed through labeling.

The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will convene 9 October to discuss...

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