Alkermes Plc files once-monthly, long-acting aripiprazole lauroxil at FDA for Schizophrenia

Alkermes plc has announced that it has submitted a New Drug Application (NDA) to the FDA for approval of aripiprazole lauroxil, the company�s investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of Schizophrenia. The data submitted as part of this NDA include the positive results from the pivotal phase III study assessing the efficacy and safety of aripiprazole lauroxil, in which aripiprazole lauroxil demonstrated significant improvements in Schizophrenia symptoms, compared to placebo.

The NDA submission follows the completion of the randomized, multicenter, double-blind, placebo-controlled, phase III study, in which both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once monthly, met the primary endpoint with statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and demonstrated significant improvements in Schizophrenia symptoms versus placebo.

Aripiprazole lauroxil is an injectable atypical antipsychotic with one-month and two-month formulations in development for the treatment of Schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available under the name Abilify. As a long-acting investigational medication based on Alkermes� proprietary LinkeRx technology, aripiprazole lauroxil is designed to have multiple dosing options and to be administered in a ready-to-use, pre-filled product format.