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.
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Alkermes’ combo pill of olanzapine and samidorphan gets US FDA approval; company predicts $10m first-year sales as schizophrenia/bipolar patients cycle through treatment options, including generics.
Alkermes’ combo pill for schizophrenia and bipolar disorder received an FDA complete response due to manufacturing questions that a physical site review might have resolved.
Built on established products and royalties from drug delivery technology, Alkermes is getting ready to launch its first novel product. Scrip talked to CEO Richard Pops about the preparations.