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Alkermes Reports the US FDA Acceptance of NDA for ALKS 3831 to Treat Schizophrenia and Bipolar I Disorder

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Alkermes Reports the US FDA Acceptance of NDA for ALKS 3831 to Treat Schizophrenia and Bipolar I Disorder

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  • The NDA is based on ENLIGHTEN-1 & 2 studies assessing the antipsychotic efficacy & weight gain with ALKS 3831 (olanzapine/samidorphan) vs PBO & Zyprexa (olanzapine) for 4 & 6wks. in patients with schizophrenia and bipolar I disorder respectively
  • Alkermes is seeking approval for FD of ALKS 3831 consisting samidorphan (10mg) co-formulated with 5/10/15/20 mg of olanzapine to address the unmet medical need of patients with schizophrenia or bipolar I disorder
  • ALKS 3831 (PO- qd) is an investigational- atypical antipsychotic therapy designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain with its anticipated PDUFA date as 15 Nov- 2019

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Alkermes


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