FDA/CDC

Alkermes submits NDA for new schizophrenia, bipolar I treatment


 

Alkermes has announced that it has submitted a New Drug Application to the Food and Drug Administration for the approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder.

Included in the application for the investigational, novel, once-daily, oral atypical antipsychotic drug candidate is data from the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy of ALKS 3831, compared with a placebo, over a 4-week period, as well as data from ENLIGHTEN-2, which compared weight gain with ALKS 3831 and olanzapine alone over a 6-month period.

“Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments,” Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes, said in a press release.

As a combination of olanzapine and samidorphan, ALKS 3831 is designed to maintain the clinical efficacy of olanzapine and mitigate the substantial weight gain that often results from taking antipsychotics. Samidorphan, an opioid receptor antagonist, is structurally related to naltrexone.

Alkermes is seeking an indication for the treatment of schizophrenia and an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy or as an adjunct to lithium or valproate, as well as for maintenance treatment of bipolar I. Dosage strength would be 10 mg of samidorphan with 5, 10, 15, or 20 mg of olanzapine.

Find the full press release on the Alkermes website.

Next Article: