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