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

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

­Alkermes’ Reports Results of Aristada (aripiprazole lauroxil) and Invega Sustenna (paliperidone palmitate) in P-IIIb ALPINE Study to Treat Schizophrenia

Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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