7:01AM Alkermes presents positive results from Phase 1 study of ALKS 3831 as a broad spectrum treatment for Schizophrenia; difference between the ALKS 3831 treatment group and the control group receiving olanzapine alone was statistically significant (ALKS) 32.84 : Co presented positive results from a phase 1 study of ALKS 3831, a novel drug candidate for the treatment of schizophrenia, in an oral session at the 53rd Annual New Clinical Drug Evaluation Unit Meeting in Hollywood, Fla. By combining a novel opioid modulator, ALKS 33, and olanzapine, an antipsychotic drug commercially available as ZYPREXA?, ALKS 3831 is designed to be a broad spectrum treatment for schizophrenia with the potential benefits of reduced weight gain associated with olanzapine and expanded utility in patients with schizophrenia and comorbid substance abuse.
The phase 1, multicenter, randomized, double-blind, placebo- and active-controlled study was designed to compare the mean change from baseline in body weight following three weeks of oral administration of ALKS 3831 in a study that included 106 healthy, normal-weight male volunteers. The safety and tolerability results for ALKS 3831 were overall similar to those observed with the olanzapine-only treatment group. Healthy volunteers who received ALKS 3831 gained an average of 2.5 kg (5.5 lbs), while subjects who received olanzapine alone gained an average of 3.4 kg. The difference between the ALKS 3831 treatment group and the control group receiving olanzapine alone was statistically significant over the three-week study period, with a trend indicating the potential for even greater differentiation over longer study periods.
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.
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