Positive Phase III results for ALKS 3831 in schizophrenia
Positive preliminary top-line results from ENLIGHTEN-1, the first of two key Phase III studies in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia, have been released by Ireland-incorporated biotech Alkermes (Nasdaq: ALKS).
ENLIGHTEN-1 was a multinational, double-blind, randomized, phase 3 study that evaluated the antipsychotic efficacy, safety and tolerability of ALKS 3831 (which combines olanzapine with samidorphan) compared to placebo over four weeks in 403 patients experiencing an acute exacerbation of schizophrenia.
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