Alkermes to initiate second Phase 2 clinical study of novel broad-spectrum oral antipsychotic

Alkermes is to initiate the second phase 2 study of ALKS 3831, a novel, oral, broad-spectrum antipsychotic medicine in development for schizophrenia. The randomised, double-blind, active-controlled study will assess ALKS 3831’s efficacy, safety and tolerability in treating schizophrenia in patients with co-occurring alcohol use disorder, compared with olanzapine, an approved and widely used atypical antipsychotic medicine. More than one-third of patients with schizophrenia have a co-occurring alcohol use disorder, a population that is commonly excluded from clinical trials and is often undertreated.

'Schizophrenia is a very challenging disease to treat and is frequently complicated by alcohol use, which can exacerbate symptoms and is associated with poor long-term outcomes,' said Dr Elliot Ehrich, Chief Medical Officer of Alkermes. 'With this innovative study, we will evaluate whether the uniquely designed attributes of ALKS 3831 improve the treatment of schizophrenia for this subpopulation of patients.'

This study is the second in the ALKS 3831 comprehensive phase 2 clinical programme; the first phase 2 study was initiated in July 2013 and is designed to evaluate the attenuation of weight gain associated with olanzapine in patients with schizophrenia. Weight gain is a common and clinically relevant metabolic side-effect of atypical antipsychotic medications, and olanzapine has one of the highest incidences and greatest amounts of weight gain among the widely prescribed products in this class of drugs.

Phase 2 study design

This phase 2, randomised, double-blind, active-controlled study is designed to assess the efficacy, safety and tolerability of ALKS 3831 in adult patients with schizophrenia and co-occurring alcohol use disorder over a treatment period of up to 15 months. Approximately 450 patients will be enrolled in the study. The objective of this study is to compare symptom exacerbation between the two treatment groups. Alkermes expects to provide topline results from the study in mid 2017.

ALKS 3831 is a proprietary investigational medicine designed as a broad-spectrum antipsychotic for the treatment of schizophrenia. ALKS 3831 is composed of samidorphan (formerly referred to as ALKS 33), a novel, 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 whose disease is exacerbated by alcohol use.