Alkermes plc, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.

The FDA classified the resubmission as a complete, Class 2 response to the Complete Response Letter (CRL) issued in November 2020, following a remote review of records requested under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (the "FDCA") relating to the manufacture of ALKS 3831 at the company's Wilmington, OH facility. Subsequent to Alkermes' resubmission of the NDA, the FDA issued a new request for records under Section 704(a)(4) of the FDCA to supplement the information previously provided by the company. Neither the CRL nor this subsequent records request identified or raised any concerns about the clinical or non-clinical data in the NDA and the FDA has not asked Alkermes to complete any new clinical trials to support approval of the application.

Alkermes will continue to work closely with the FDA as it completes its review of the ALKS 3831 NDA and remains committed to making ALKS 3831 available to patients as quickly as possible.

Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal). An estimated 2.4 million American adults have schizophrenia, with men and women affected equally.

Bipolar disorder is a brain disorder that causes shifts in a person's mood, energy and ability to function. Individuals with this brain disorder may experience debilitating mood shifts from extreme highs (mania) to extreme lows (depression). Bipolar I disorder is characterized by the occurrence of at least one manic episode, with or without the occurrence of a major depressive episode, and affects approximately one per cent of the adult population in the United States in any given year.

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.