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