Alkermes is seeking FDA approval for its investigational antipsychotic drug candidate ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder, according to a press release.
The agency accepted the company’s New Drug Application (NDA) with an assigned Prescription Drug User Fee Act target action date of November 15, 2020.
ALKS 3831 is a once-daily, oral atypical antipsychotic treatment that is composed of samidorphan, a novel, new molecular entity and co-formulated with the established agent olanzapine. The fixed dosage strengths of 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine are being evaluated.
The NDA submission is backed by data from the ENLIGHTEN clinical development program in patients with schizophrenia. The program included 2 key studies, ENLIGHTEN-1 and ENLIGHTEN-2, as well as supportive studies evaluating the pharmacokinetic and metabolic profile and long-term safety of ALKS 3831. The ENLIGHTEN-1 study assessed the antipsychotic efficacy of ALKS 3831 compared with placebo over 4 weeks and the ENLIGHTEN 2 study evaluated weight gain with ALKS 3831 compared with olanzapine over 6 months. The program also included pharmacokinetic bridging data comparing ALKS 3831 with olanzapine.
“The acceptance of the NDA for ALKS 3831 marks an important milestone toward our goal of offering a new treatment option to people living with schizophrenia or bipolar I disorder. The ALKS 3831 development program builds on Alkermes’ commitment to developing new therapeutic options that seek to address unmet needs of patients in large therapeutic areas,” Craig Hopkinson, MD, chief medical officer at Alkermes, said in a statement. “We believe ALKS 3831 has the potential to be a meaningful new offering for patients with these serious and complex mental health disorders, and we look forward to engaging with the FDA throughout the NDA review process.”
1. Alkermes Announces US Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder [news release]. Alkermes’ website. https://investor.alkermes.com/news-releases/news-release-details/alkermes-announces-us-food-and-drug-administration-acceptance. Accessed January 29, 2020.