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

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.