Biopharmaceutical company Alkermes has started Phase II study of ALKS 3831, a broad spectrum oral antipsychotic with proprietary combination of a novel opioid modulator ALKS 33, for the treatment of schizophrenia.
The double-blind, active-controlled study is designed to assess the safety, tolerability and efficacy of ALKS 3831 and olanzapine, an approved atypical antipsychotic medicine, compared to olanzapine alone.
In addition, ALKS 3831's impact on weight and other metabolic factors in patients will be evaluated and the attenuation of weight gain induced by olanzapine observed in the Phase I study will be confirmed.
Alkermes chief medical officer Dr Elliot Ehrich said ALKS 3831 was designed as a broad spectrum schizophrenia agent, addressing two specific patient subpopulations.
The subpopulations include patients who may benefit from attenuation of the significant weight gain often associated with olanzapine treatment and patients with a dual diagnosis of substance abuse disorder, which often exacerbates their schizophrenia.
"This large, well-designed phase study will provide data necessary for us to determine ALKS 3831's ability to attenuate weight gain commonly associated with olanzapine treatment," Ehrich added.
Following a one-week oral lead-in of olanzapine, around 400 schizophrenia patients will be randomised for 12 weeks with olanzapine or three varying doses of ALKS 3831, all patients will be given ALKS 3831 for a 12-week period.
The study is one of the two separate studies of ALKS 3831 comprehensive Phase II clinical programme, while the other is designed to investigate its potential utility for the patients with the dual diagnosis of schizophrenia and substance abuse disorder.
Topline results from the study are expected in the first half of 2015.