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Alkermes completes patient enrollment in Phase II ALKS 3831 trial to treat schizophrenia

Alkermes has completed patient enrollment in a double-blind, active-controlled, dose-ranging Phase II trial of ALKS 3831, an investigational, novel, oral, broad-spectrum atypical antipsychotic medicine, to treat schizophrenia.

ALKS 3831 is composed of samidorphan, a new, potent mu-opioid antagonist, in combination with an antipsychotic drug, olanzapine.

The trial is designed to evaluate the efficacy, safety and tolerability of ALKS 3831 in the treatment of schizophrenia and its attenuation of weight gain, compared with olanzapine.

A total of 309 patients at multiple centers in the US and Europe have been enrolled in the double-blind, olanzapine-controlled phase II trial.

Topline results from the 12-week, double-blind treatment period of this Phase II trial are expected to be announced in early 2015.

The company said that double-blind treatment period will be followed by an additional 12-week period in which all patients will receive ALKS 3831.

Alkermes chief medical officer Dr Elliot Ehrich said there is a clear and compelling clinical rationale for developing an antipsychotic with the efficacy of olanzapine and a safety profile that addresses the negative health impact of weight gain associated with olanzapine.

"This clinical study of ALKS 3831 is designed to evaluate the efficacy of ALKS 3831 in the treatment of schizophrenia and its ability to attenuate olanzapine-associated weight gain.

"We are pleased to have now completed enrollment and look forward to reporting the results from this study early next year."

The study is the first of two studies in the ALKS 3831 Phase II clinical program.

The second Phase II trial was started in June 2014 and is designed to assess ALKS 3831 for the treatment of patients with schizophrenia and alcohol use.