Alkermes mid-stage antipsychotic stays on track
Alkermes is hoping to move into late-stage study of its investigational schizophrenic drug ALKS 3831 after the oral treatment showed comparable efficacy to existing drug olanzapine, but with better control of patient weight, the firm said yesterday.
Patients on the two-drug combo, which combines the now off-patent olanzapine with a novel drug called samidorphan, showed 37% lower mean weight gain than those taking onlyolanzapine, Alkermes said.
Weight-gain concerns have led to warnings on the label of olanzapine, the generic of Eli Lilly's Zyprexa, according to The Wall Street Journal.
Based on the positive results, Alkermes said it plans to ask FDA for an “End-of-Phase 2 meeting.”