Alkermes provided an update on its regulatory strategy for ALKS 3831 (olanzapine/samidorphan), the company’s novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine, while mitigating olanzapine-associated weight gain. Following a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company plans to expand the NDA for ALKS 3831 to encompass the treatment of bipolar I disorder, in addition to the treatment of schizophrenia.
The ALKS 3831 NDA, which the company now plans to submit in the fourth quarter of 2019, will include data from the completed ALKS 3831 ENLIGHTEN clinical development program in individuals with schizophrenia as well as pharmacokinetic bridging data comparing ALKS 3831 and ZYPREXA® (olanzapine). According to Craig Hopkinson, M.D., chief medical officer and senior vice president of Medicines Development and Medical Affairs at Alkermes, Alkermes is honored to extend their commitment and dedication of developing new medicines in treating serious mental illness to individuals with bipolar I disorder.
The ALKS 3831 NDA will include data to support an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as a monotherapy or adjunct to lithium or valproate and for maintenance treatment of bipolar I disorder; and an indication for the treatment of schizophrenia. The proposed fixed dosage strengths for ALKS 3831 include 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
Alkermes is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system diseases and oncology. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction, multiple sclerosis, and cancer. Headquartered in Dublin, Ireland, Alkermes has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
This was reported by Alkermes on July 15, 2019. ‘