Alkermes plc is expanding its New Drug Application (NDA) for the investigational drug ALKS 3831—a combination of the antipsychotic olanzapine and the novel molecular entity samidorphan—to include the treatment of bipolar I disorder as well as schizophrenia, the drugmaker recently announced.
The announcement followed a meeting between Alkermes and the US Food and Drug Administration (FDA). The once-daily oral drug is designed to provide the antipsychotic efficacy of olanzapine while mitigating weight gain.
“We are pleased to have met with FDA to align on this regulatory review pathway for ALKS 3831 for the treatment of bipolar I disorder, based on pharmacokinetic bridging data and results from our ENLIGHTEN program for schizophrenia,” said Craig Hopkinson, MD, chief medical officer and senior vice president of medicines development and medical affairs at Alkermes.
“Our NDA preparation is well underway, and we anticipate submitting a single NDA for ALKS 3831 later this year for the treatment of schizophrenia and bipolar I disorder.”
The application will include data supporting 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. It will also request an indication for the treatment of schizophrenia.
Alkermes plans to submit the ALKS 3831 NDA during the fourth quarter of 2019. The proposed dosage strengths of ALKS 3831 are 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg, or 20 mg of olanzapine.
ENLIGHTEN includes two key studies involving patients with schizophrenia. ENLIGHTEN-1 evaluated the antipsychotic efficacy of ALKS 3831 compared with placebo over 4 weeks. ENLIGHTEN-2 assessed weight gain with ALKS 3831 compared with olanzapine over 6 months. The program also includes supportive studies that evaluated the pharmacokinetic and metabolic profile and long-term safety of ALKS 3831, and pharmacokinetic bridging data comparing ALKS 3831 and Zyprexa (olanzapine).