Following the announcement of positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the FDA in support of Alkermes’ ALKS-3831 for the treatment of Schizophrenia and Bipolar I Disorder;

Alessio Brunello, Managing Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“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.

“Alkermes’ ALKS-3831(samidorphan with olanzapine) aim at reducing the metabolic abnormalities associated with current treatments for schizophrenia. The candidate consists of olanzapine combined with a samidorphan, a μ-opioid receptor antagonist aimed at decreasing the metabolic effects associated with olanzapine. Alkermes is expected to play a greater role in the schizophrenia market and with ALKS-3831, the company will be able to expand its presence in this market. GlobalData forecasts ALKS-3831 to have peak sales of $364m in 2026.

“ALKS-3831 has a Prescription Drug User Fee Act (PDUFA) date of 15 November 2020. Although Alkermes primarily studied patients with schizophrenia during clinical development, the company submitted pharmacokinetic bridging data comparing ALKS-3831 to olanzapine in patients with bipolar I disorder as part of its NDA. If the drug will be approved for schizophrenia, it is likely to expect approval for the bipolar indication as olanzapine is already used in both indications.

“According to GlobalData, if ALKS-3831 is approved, many olanzapine prescribers would attempt to switch their patients to ALKS-3831 when possible. Payer barriers such as stringent prior authorization and copayment requirements could dramatically reduce the actual market uptake.”