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Regulatory Approval Sought for Long-Acting Schizophrenia Treatment Aripiprazole Lauroxil

Injectable agent is administered once a month

A new drug application (NDA) has been submitted to the FDA for approval of aripiprazole lauroxil (Alkermes PLC), an investigational, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia.

The NDA included positive results from a pivotal phase III study in which aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms compared with placebo.

In the randomized, double-blind, placebo-controlled trial, both doses of aripiprazole lauroxil (441 mg and 882 mg) administered once monthly met the primary endpoint, achieving 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, and the observed safety profile was similar to that of oral aripiprazole. The most common adverse events included insomnia, akathisia, and headache.

Aripiprazole lauroxil is an injectable atypical antipsychotic with 1- 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 America Pharmaceutical, Inc.). As a long-acting investigational medication based on the proprietary LinkeRx technology (Alkermes), aripiprazole lauroxil is designed to have multiple dosing options and to be administered in a ready-to-use, prefilled 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 American adults have schizophrenia, with men and women affected equally.

Worldwide, it is estimated that one person in every 100 develops schizophrenia, 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 and that allow health care providers to track patient adherence.

Source: Alkermes; August 25, 2014.

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