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ARTICLE | Clinical News

Alkermes planning NDA for schizophrenia combo after passing weight gain test

November 29, 2018 9:15 PM UTC

Alkermes plc (NASDAQ:ALKS) said it plans to submit an NDA to FDA mid-2019 for ALKS 3831 after reporting that the samidorphan/olanzapine combination tablet led to less weight gain in schizophrenics than olanzapine alone in the Phase III ENLIGHTEN-2 trial. The schizophrenia market is dominated by generics with proven efficacy but Alkermes believes the compound's favorable weight profile could offer an advantage as olanzapine has a high incidence and magnitude of weight gain, a common side effect with atypical antipsychotics.

Among 538 evaluable patients in ENLIGHTEN-2, once-daily oral ALKS 3831 met both co-primary endpoints of a lower mean percent weight gain from baseline (4.21% vs. 6.59%) and a lower proportion of patients who gained 10% or more of their baseline body weight (17.8% vs. 29.8%) vs. olanzapine at six months (p=0.003 for both). ALKS 3831 also met the secondary endpoint of a lower proportion of patients who gained 7% or more of their baseline body weight at six months vs. olanzapine (27.5% vs. 42.7%, p=0.001). ...

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