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Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder
DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug
About this update from Alkermes Plc
[{"type":"text","content":"DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder. ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. The ALKS 3831 NDA includes data from the ENLIGHTEN clinical development program in patients with schizophrenia, as well as pharmacokinetic (PK) bridging data comparing ALKS 3831 and ZYPREXA® (olanzapine). \n\"Antipsychotic medications are an important part of the treatment paradigm for both schizophrenia and bipolar I disorder, yet there remains a persistent unmet need for new treatments,\" said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. \"The ALKS 3831 NDA submission exemplifies Alkermes' commitment to developing new therapies to treat serious and prevalent central nervous system disorders and our longstanding dedication to people living with mental health disorders. We are pleased to have submitted an application seeking approval of ALKS 3831 for both of these indications, and we look forward to working with the agency to bring this potential new medication to patients and healthcare professionals.\"\nThe ALKS 3831 NDA includes data to support an indication for the treatment of schizophrenia, and 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. Alkermes is seeking approval of fixed dosage strengths of ALKS 3831 composed of 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.\nAbout the ENLIGHTEN Clinical Development Program The ENLIGHTEN clinical development program for ALKS 3831 includes two key studies in patients with schizophrenia: the ENLIGHTEN-1 study, which evaluated the antipsychotic efficacy of ALKS 3831 compared to placebo over four weeks, and the ENLIGHTEN-2 study, which assessed weight gain with ALKS 3831 compared to olanzapine over six months. The progra...