Alkermes Presents Positive Phase 3 Data For Schizophrenia Drug

Alkermes announced that it has presented data from its phase 3 clinical trial of aripiprazole lauroxil for the treatment of schizophrenia at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Hollywood.

Aripiprazole lauroxil is an injectable atypical antipsychotic which, once inside the body, converts into aripiprazole. Aripiprazole is commercially available under the brand name ABILIFY. The drug is designed to have multiple dosing options including one-month and two-month formulations.

The multicenter, randomized, double-blind, placebo-controlled Phase III study assessed the efficacy, safety and tolerability of aripiprazole lauroxil in 623 patients experiencing acute exacerbation of schizophrenia. Results show that both doses of once-monthly aripiprazole lauroxil investigated in the trial met their primary endpoints with meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores. The trial also met its secondary endpoints.

Serge Stankovic, Senior Vice President of Clinical Development and Medical Affairs at Alkermes, said, “With these compelling phase 3 data in hand, we are moving forward expeditiously to bring aripiprazole lauroxil to patients with schizophrenia and their families. With a deep background in the development of long-acting injectable antipsychotic medicines, our scientists designed aripiprazole lauroxil rationally, in a ready-to-use format with multiple dosing options, to meet the individual needs of patients and the physicians and nurses who treat them.”

Schizophrenia is a chronic, severe and debilitating brain disorder. The disease is characterized by positive symptoms such as hallucinations and delusions, as well as negative symptoms like depression and social withdrawal. Around 2.4 million people in the U.S. are afflicted with schizophrenia, both men and women. Schizophrenia remains one of the most serious types of mental illness, with an estimated 1 in every 100 affected around the world.

The company said it is on track to submit a New Drug Application (NDA) for aripiprazole lauroxil as treatment for schizophrenia to the FDA in the third quarter of the year.