DUBLIN—Alkermes plc has announced the results of its Phase 3 study of its long-acting injectable (LAI) compound aripiprazole lauroxil, a once-monthly, atypical antipsychotic for the treatment of schizophrenia. The study was a randomized, double-blind, placebo-controlled clinical trial in patients with schizophrenia. Those who received aripiprazole lauroxil in either 441 mg or 882 mg doses showed statistically significant reductions from baseline in Positive and Negative Syndrome Scale total scores after 12 weeks. Aripiprazole lauroxil successfully met both its primary and secondary endpoints of efficacy and improvement on the Clinical Global Impression – Improvement scale, respectively, and was generally well tolerated, with a safety profile similar to that of oral aripiprazole. The most common adverse events reported were insomnia, headache and akathisia (restlessness).
Alkermes plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration for aripiprazole lauroxil in the third quarter of this year.
“These statistically significant efficacy data demonstrate aripiprazole lauroxil’s ability to provide clinically meaningful symptom control in patients struggling with schizophrenia,” said Dr. Henry Nasrallah, chair of the Department of Neurology and Psychiatry at Saint Louis University School of Medicine. “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. These data come at a time when the treatment landscape for schizophrenia is evolving; more physicians are now recognizing the benefits of long-acting injectable antipsychotics and considering their use earlier in disease progression.”
At present, LAI antipsychotics only account for 10 percent of the $12-billion U.S. market for atypical antipsychotics. This subset of medication is growing, however, due to a number of benefits. As noted in the paper “The costs of schizophrenia,” published in the Journal of Clinical Psychiatry in 2007, up to two-thirds of schizophrenia patients do not adhere to oral medication regimens. The paper reports that up to 80 percent of outpatients demonstrate poor compliance with schizophrenia medication regimens, with only 50 percent remaining compliant to the regimen one month after being discharged and only 30 percent remaining compliant after two years. Studies comparing LAIs and oral antipsychotics have shown that LAIs see better adherence, which is accompanied by lower relapse and hospitalization rates.
In a February 2014 press release detailing results from a new report, GlobalData forecasts that the global schizophrenia treatment market will grow from $6.3 billion in 2012 to $7.9 billion by 2022 at a compound annual growth rate of 2.4 percent. The consulting firm attributed the growth to “increasing utilization of [LAI] antipsychotics,” as well as an increase in mental health awareness. Dr. Kyle Nicholson, GlobalData’s analyst covering neurology, noted that aripiprazole lauroxil, along with Johnson & Johnson’s Invega Sustenna, “will introduce new LAI treatments and expand the global market options by 33 percent … As novel products in an emerging part of the schizophrenia drug market, these agents could be met with significant sales, due to their higher costs of therapy and a growing popularity of LAIs in this space.”
Alkermes plans to establish a specialty sales force to market aripiprazole lauroxil. Should the drug secure regulatory approval, Alkermes plans to recruit its sales force beginning next year.
“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,” Richard Pops, CEO of Alkermes, said in a news release. “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 U.S. National Institute of Mental Health defines schizophrenia as “a chronic, severe and disabling mental disorder characterized by deficits in thought processes, perceptions and emotional responsiveness.” The disorder affects 2.4 million Americans and some 24 million people worldwide, according to the World Health Organization.
