Alkermes announces PDUFA date for ALKS 3831

In November last year, Ireland-incorporated biotech Alkermes (Nasdaq: ALKS) submitted  a New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and bipolar I disorder, and today announced that the US Food and Drug Administration has accepted the NDA for review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2020, with the news sending the firm’s share up 4% premarket.

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine – Eli Lilly’s (NYSE: LLY) Zyprexa - while mitigating olanzapine-associated weight gain. Weight gain is a common and clinically relevant side effect of atypical antipsychotic medications. Olanzapine is a very effective and important antipsychotic treatment option for patients, but its clinical use has been limited due to its high risk of weight gain. If approved, ALKS 3831 has the potential to offer a new treatment option to patients living with these two serious and complex mental health disorders.

"The acceptance of the NDA for ALKS 3831 marks an important milestone toward our goal of offering a new treatment option to people living with schizophrenia or bipolar I disorder. The ALKS 3831 development program builds on Alkermes' commitment to developing new therapeutic options that seek to address unmet needs of patients in large therapeutic areas," said Dr Craig Hopkinson, chief medical officer at Alkermes. "We believe ALKS 3831 has the potential to be a meaningful new offering for patients with these serious and complex mental health disorders, and we look forward to engaging with the FDA throughout the NDA review process," he added.

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 olanzapine, 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 10mg of samidorphan co-formulated with 5mg, 10mg, 15mg or 20mg of olanzapine.