FDA Committee Endorses Alkermes Treatment That Combines Olanzapine With An Opioid Receptor Antagonist To Prevent Metabolic Side Effects

Alkermes reported that its drug candidate ALKS 3831, which combines the antipsychotic olanzapine with the opioid receptor antagonist samidorphan to mitigate the common metabolic side effects of olanzapine, received favorable votes from the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. ALKS 3831 is intended as treatment for adults with schizophrenia or bipolar I disorder.

ALKS 3831 is intended to provide the effectiveness of olanzapine and to mitigate or prevent olanzapine's common side effects of weight gain and metabolic disorders. After reviewing the evidence presented by Alkermes . . .