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Alkermes plc announced the publication of phase III ENLIGHTEN-1 trial of ALKS 3831 in the Journal of Clinical Psychiatry .
Alkermes plc announced the publication of results from the phase III ENLIGHTEN-1 clinical trial of ALKS 3831 (olanzapine/samidorphan) in the peer-reviewed publication, Journal of Clinical Psychiatry . ENLIGHTEN-1 was a four-week study evaluating the efficacy, safety and tolerability of ALKS 3831 compared to placebo in 403 patients experiencing an acute exacerbation of schizophrenia.
Positive topline data from the ENLIGHTEN-1 study were first reported in June 2017 . A New Drug Application (NDA) for ALKS 3831 is currently under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of 15 November 2020 . ENLIGHTEN-1 is one of two key studies included in the ALKS 3831 ENLIGHTEN clinical development program.
ENLIGHTEN-2, the second phase III study, assessed weight gain with ALKS 3831 compared to olanzapine over six months. Positive topline data from the ENLIGHTEN-2 study were reported in November 2018.
See-"Efficacy and Safety of a Combination of Olanzapine and Samidorphan in Adult Patients With an Acute Exacerbation of Schizophrenia:Outcomes From the Randomized, Phase III ENLIGHTEN-1 Study"; Steven G. Potkin, MD; Jelena Kunovac, MD,; Bernard L. Silverman, MD; Adam Simmons, MPH; Ying Jiang, PhD; Lauren DiPetrillo, PhD; and David McDonnell, MD- Clin Psychiatry 2020;81(2):19m12769.
Condition: Schizophrenia + Bipolar Disorder
Type: drug
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