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Alkermes submits NDA to FDA for schizophrenia drug aripiprazole lauroxil

Ireland-headquartered biopharmaceutical firm Alkermes has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for aripiprazole lauroxil to treat schizophrenia.

Aripiprazole lauroxil is an investigational, new, once-monthly, long-acting injectable atypical antipsychotic.

The NDA is based on the positive results from the randomized, multicenter, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of aripiprazole lauroxil, in which the drug showed improvements in schizophrenia symptoms, compared to placebo.

Alkermes chief executive officer Richard Pops said the company has designed aripiprazole lauroxil to be a differentiated treatment option for schizophrenia, with a ready-to-use format with multiple dosing options, to help meet the individual needs of patients and their healthcare providers.

"These attributes, together with the robust clinical data observed in the pivotal study, position aripiprazole lauroxil to be a meaningful new entrant in the growing long-acting injectable antipsychotic market, and we look forward to working with the FDA to bring this important new medication to patients and physicians as quickly as possible," Pops said.

In the phase III trial, both doses of aripiprazole lauroxil tested, 441mg and 882mg administered once monthly, met the primary endpoint, and secondary endpoints as well as showed significant improvements in schizophrenia symptoms versus placebo.