Alkermes to expand the proposed NDA for ALKS 3831 to include bipolar 1 disorder as well as schizophrenia .

Alkermes provided an update on its regulatory strategy for ALKS 3831 (olanzapine/samidorphan), the company's investigational, 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 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 patients with schizophrenia as well as pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine).

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.