Alkermes plc 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 U.S. Food and Drug Administration (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).
“Bipolar I disorder is a complicated and often misdiagnosed disease, characterized by severe shifts in mood and energy that can impact a person’s ability to complete day-to-day activities. Antipsychotics are a mainstay treatment option for many people living with bipolar I disorder; however, new treatments with differentiated efficacy and tolerability profiles are needed,”
said Roger S. McIntyre, M.D., Professor of Psychiatry and Pharmacology at the University of Toronto, Head of the Mood Disorders Psychopharmacology Unit at the University Health Network in Toronto and Director for the Depression and Bipolar Support Alliance (DBSA).
“A potential new medication like ALKS 3831 would be a meaningful addition to the bipolar I disorder treatment landscape.”
“As a longstanding leader dedicated to developing new medicines to treat schizophrenia and other serious mental health disorders, we are gratified to now extend that commitment to people living with bipolar I disorder,”
said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes.
“We are pleased to have met with FDA to align on this regulatory review pathway for ALKS 3831 for the treatment of bipolar I disorder, based on pharmacokinetic bridging data and results from our ENLIGHTEN program for schizophrenia. Our NDA preparation is well underway and we anticipate submitting a single NDA for ALKS 3831 later this year for the treatment of schizophrenia and bipolar I disorder.”
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.