Alkermes' Schizophrenia Drug Meets Phase III Trial Endpoints
Alkermes announced that the Phase III trial investigating its drug aripiprazole lauroxil in patients with schizophrenia hit its key primary endpoints.
The double-blind, randomized, placebo-controlled Phase 3 clinical trial’s prespecified primary endpoint was statistically significant reduction from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12 against placebo.
Henry Nasrallah, chair of the department of neurology and psychiatry at Saint Louis University School of Medicine, said, “These statistically significant efficacy data demonstrate aripiprazole lauroxil’s ability to provide clinically meaningful symptom control in patients struggling with schizophrenia. A once-monthly version of aripiprazole with multiple dose strengths would be a welcome addition since it would enhance current treatment options and provide dosing flexibility.”
Aripiprazole lauroxil is an investigational novel, long acting injectable antipsychotic agent intended to provide patients with once-monthly dosing. Once the medication is in the body it converts to aripiprazole, also known commercially as Abilify.
The drug was well tolerated in general in the Phase III study. Its safety profile was comparable to the established safety profile of oral aripiprazole. Alkermes will present data from the study at an upcoming medical meeting. Results will also be submitted for publication in a peer-reviewed journal.
Richard Pops, CEO of Alkermes, said, “Our goal has been to develop a differentiated long-acting injectable product candidate responsive to the real-world needs of patients and healthcare providers, providing the proven efficacy of aripiprazole administered once-monthly in a ready-to-use format with multiple dosage strengths. With these positive data in hand, we will complete the preparation of our NDA, which we plan to submit next quarter, and continue our preparations to bring this important new medicine to patients and healthcare providers.”
The company said it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of the year based on the Phase III study’s positive results.