The U.S. Food and Drug Administration (FDA) has acknowledged receipt of a New Drug Application (NDA) resubmitted by Alkermes plc for ALKS 3831 (olanzapine/samidorphan). The medication is intended to treat adults with schizophrenia and adults with bipolar I disorder. The FDA assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.
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.
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 (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 plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.
This was reported by Alkermes plc on December 29, 2020.
Contact information: Marisa Borgasano, Associate Director, Corporate Communications, Public Affairs, Alkermes plc, Waltham, Massachusetts Facility, 852 Winter Street, Waltham, MA 02451; +1 781 609 6659; Website: http://www.alkermes.com
