Promising future for Alkermes' ALKS-3831 in the schizophrenia market, says analyst

The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the US Food and Drug Administration returned a positive vote on Alkermes’ (Nasdaq: ALKS) ALKS 3831 (olanzapine/samidorphan), an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.

The committees jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that the safety profile of ALKS-3831 has been adequately characterized (13 yes, 3 no, 1 abstention).

Commenting on the news, analy00tics firm GlobalData’s pharma analyst Alessio Brunello said that the development of drugs with enhanced safety profiles has been consistently an unmet need for schizophrenia. The most notable side effect caused by current treatments are metabolic effects, such as weight gain and EPS. Metabolic syndrome is the most challenging aspect when treating schizophrenic patients. This is further compounded by the fact that, compared to other side effects caused by current therapies, metabolic abnormalities are much more difficult to treat or reverse, especially in the long-term.