WASHINGTON (dpa-AFX) - Alkermes plc (ALKS) reported positive results from a phase 1 study of ALKS 3831, a drug candidate for the treatment of schizophrenia.
ALKS 3831 is an investigational medicine designed as a broad spectrum treatment for schizophrenia. ALKS 3831 is comprised of ALKS 33, a opioid modulator that acts as a potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine. ALKS 3831 is designed to attenuate olanzapine-induced metabolic side effects, including weight gain, and to have utility in patients with schizophrenia and comorbid substance abuse.
The company said, in the phase 1 study, subjects who received once-daily, oral administration of ALKS 3831 for three weeks demonstrated significantly less weight gain compared to subjects taking olanzapine. Data from the phase 1 study showed that ALKS 3831 had a safety and tolerability profile similar to that observed in the olanzapine-only treatment group.
Based on the positive results of the phase 1 study, Alkermes plans to initiate a phase 2 dose-ranging study of ALKS 3831 in mid calendar 2013. The study will evaluate ALKS 3831's safety and effects on metabolic outcomes, including weight gain, in patients with schizophrenia.
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