Alkermes initiates phase III ALKS 9070 study for schizophrenia
Alkermes has initiated a phase III clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070 is designed to provide patients with once-monthly dosing of a medication that, once in the body, converts into aripiprazole, a molecule that is commercially available under the name ABILIFY for the treatment of a number of central nervous system (CNS) disorders.
In June 2011, Alkermes announced data from a phase Ib double-blind, randomized, placebo-controlled clinical study of ALKS 9070 in 32 patients with schizophrenia. Data from the study showed that ALKS 9070 was generally well tolerated and achieved therapeutically relevant plasma concentrations of aripiprazole with a pharmacokinetic profile that supports once-monthly dosing.
The phase III randomized, multicenter, double-blind study is designed to assess the efficacy, safety and tolerability of ALKS 9070 compared to placebo in patients experiencing acute exacerbation of schizophrenia. Approximately 690 subjects will be randomized to receive once-monthly intramuscular injections of ALKS 9070 300 mg, ALKS 9070 600 mg or placebo for twelve weeks. In addition, subjects will receive oral study drug for the first three weeks after randomization. Subjects randomized to one of the two ALKS 9070 treatment groups will receive oral aripiprazole, while subjects randomized to the placebo group will receive matching oral placebo. The primary efficacy endpoint of the study is the change in Positive and Negative Syndrome Scale (PANSS) total score from baseline. All participants in the double-blind portion of the study will be eligible to continue in an open-label phase and receive ALKS 9070 for an additional 12 months. The objective of the extension phase of the study is to assess the safety and long-term durability of effect of once-monthly ALKS 9070.