— New Once-Monthly Product Candidate for Treatment of Schizophrenia, in a Ready-to-Use Format With Multiple Dose Strengths —
— FDA Action Expected by Aug. 22, 2015 —
DUBLIN, Ireland I October 22, 2014 I Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, the company’s investigational, novel, once-monthly injectable atypical antipsychotic for the treatment of schizophrenia. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s target action date for the aripiprazole lauroxil NDA is Aug. 22, 2015.
“The FDA acceptance of the aripiprazole lauroxil NDA marks the achievement of an important milestone for this program and brings us another step closer to offering patients and physicians a new treatment option for schizophrenia with distinctive features, including a range of doses and ready-to-use format,” stated Richard Pops, Chief Executive Officer of Alkermes. “If approved, aripiprazole lauroxil could be a significant new entrant in the increasingly important category of long-acting injectable medicines for schizophrenia.”
The NDA filing included the positive results from the pivotal phase 3 study assessing the efficacy and safety of aripiprazole lauroxil, in which aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms, compared to placebo. In the randomized, multicenter, double-blind, placebo-controlled study, 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 was generally well tolerated in the study, and the observed safety profile of aripiprazole lauroxil was similar to that reported with oral aripiprazole. The most common adverse events in the study were insomnia, akathisia and headache.
About Aripiprazole Lauroxil
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.
About Schizophrenia and Long-Acting Medicines
Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million American adults have schizophrenia,1 with men and women affected equally. Worldwide, it is estimated that one person in every 100 develops schizophrenia, which is one of the most serious types of mental illness. Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period of time2 and allow healthcare providers to track patient adherence.3
About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia and Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
SOURCE: Alkermes
