Alkermes plc (NASDAQ: ALKS) today announced the initiation of the second phase 2 study of ALKS 3831, a novel, oral, broad-spectrum antipsychotic medicine in development for schizophrenia. The randomized, 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 to 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 Elliot Ehrich, M.D., 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 program; 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.