Alkermes plc (NASDAQ: ALKS) today announced the initiation of a phase 3 clinical trial of ALKS 9070 for the treatment of schizophrenia. ALKS 9070, a proprietary Alkermes molecule, 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. The multicenter, double-blind, placebo-controlled study is designed to assess the efficacy, safety and tolerability of ALKS 9070 in approximately 690 patients experiencing acute exacerbation of schizophrenia. The clinical data from this study, expected mid-calendar 2013, will form the basis of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ALKS 9070 for the treatment of schizophrenia, a chronic brain disease.
“Multiple studies have shown that long-acting therapies in the treatment of schizophrenia can lead to improved patient outcomes and reduced costs”
"Multiple studies have shown that long-acting therapies in the treatment of schizophrenia can lead to improved patient outcomes and reduced costs," stated Dr. Herbert Meltzer, Professor of Psychiatry at Feinberg School of Medicine and Director of the Division of Neuropsychopharmacology at Northwestern University. "An extended-release injectable medication that incorporates the unique clinical properties and established safety and efficacy of aripiprazole would represent a significant treatment advancement for patients and physicians to manage this serious, chronic disease."
In June 2011, Alkermes announced data from a phase 1b 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.
"Alkermes' expertise in developing safe and effective long-acting therapeutics uniquely positions us to develop a once-monthly atypical antipsychotic medication that delivers aripiprazole, a widely prescribed oral product with an established safety and efficacy profile," stated Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. "The advancement of ALKS 9070 into pivotal development marks an important milestone for the program, and we look forward to seeing the results in mid-2013."