Biopharmaceutical company Alkermes (NaddaqGS:ALKS) revealed on Monday the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for approval of aripiprazole lauroxil for the treatment of schizophrenia, a chronic, severe and disabling brain disorder.
The company said that the NDA data includes the positive results from the pivotal phase 3 study assessing the efficacy and safety of aripiprazole lauroxil, with aripiprazole lauroxil demonstrating significant improvements in schizophrenia symptoms, compared to placebo.
In the company’s randomized, multicentre, double-blind, placebo- controlled, phase 3 study, both the doses of aripiprazole lauroxil, 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, concluded the company