FDA Sets PDUFA Date on Olanzapine, Samidorphan Combination Therapy for Schizophrenia

The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020 for olanzapine/samidorphan (ALKS 3831), a novel treatment for schizophrenia and bipolar I disorder.

The treatment, produced by Alkermes plc, is an investigational, once-daily, oral atypical antipsychotic drug candidate aimed at providing the efficacy of olanzapine without the associated weight gain.

The NDA includes data from the ENLIGHTEN clinical development program, a pair of trials for patients with schizophrenia, as well as pharmacokinetic bridging data comparing the new treatment with olanzapine.

The ENLIGHTEN-1 study evaluated the antipsychotic efficacy of the combination therapy compared to placebo over 4 weeks, while the ENLIGHTEN-2 study assessed weight gain with the medication compared to olanzapine over 6 months.

The investigators looked at an indication for the treatment of schizophrenia and an indication for the treatment of manic and mixed episodes associated with bipolar I disorder as a monotherapy or adjunct to lithium or valproate and for maintenance treatment of bipolar I disorder.

Alkermes is seeking approval for fixed dosage strengths of the treatment composed of 10 mg of samidorphan co-formulated with 5, 10, 15, or 20 mg of olanzapine.

“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.”