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FDA Accepts New Drug Application for Aripiprazole Lauroxil for Treatment of Schizophrenia

Agency action expected by August 2015

The FDA has accepted for filing a new drug application for aripiprazole lauroxil (Alkermes), an investigational, 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 August 22, 2015.

The NDA filing included positive results from a pivotal phase III study that assessed the efficacy and safety of aripiprazole lauroxil, in which the treatment demonstrated significant improvements in schizophrenia symptoms compared with placebo.

In the randomized, double-blind, placebo-controlled study, both doses of aripiprazole lauroxil tested (441 mg and 882 mg), administered once monthly, met the trial’s primary endpoint, demonstrating statistically significant and clinically meaningful reductions in Positive and Negative Syndrome Scale (PANSS) scores. The treatment also met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms compared with placebo.

Aripiprazole lauroxil was generally well tolerated in the study, and the drug’s observed safety profile was similar to that reported with oral aripiprazole. The most common adverse events were insomnia, akathisia, and headache.

Aripiprazole lauroxil is an injectable atypical antipsychotic with 1-month and 2-month formulations in development for the treatment of schizophrenia. Once in the body, aripiprazole lauroxil converts to aripiprazole, which is commercially available under the trade name Abilify (Otsuka Pharmaceutical Company). As a long-acting investigational medication, aripiprazole lauroxil is designed to have multiple dosing options and to be administered in a ready-to-use, pre-filled product format.

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 adults in the U.S. have schizophrenia, 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 schizophrenia patients with blood concentrations of active drug that remain within a therapeutic range for an extended period, thereby allowing health care providers to track patient adherence.

Source: Alkermes; October 22, 2014.

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