ALKS 9070, a Alkermes molecule, is designed to provide 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 various central nervous system (CNS) disorders.
The multicenter, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of ALKS 9070 in around 690 schizophrenia patients.
The company hopes to release the data in the mid of 2013, which is likely to form the basis of a New Drug Application (NDA) to the US FDA.
Alkermes previously announced data from a phase 1b double-blind, randomized, placebo-controlled clinical study of ALKS 9070 in 32 patients with schizophrenia which showed that ALKS 9070 was well tolerated.