The USFDA has received the Aripiprazole Lauroxil NDA, submitted by Ireland-based Alkermes for treating patients with schizophrenia. Alkermes shares gained almost 2.3% on the news.
Aripiprazole lauroxil is a partial dopamine agonist of the second generation class of antipsychotics, with one-month and two-month formulations, developed for the treatment of the mental disorder schizophrenia, which is a chronic, severe and disabling brain disorder.
Alkermes has submitted the NDA based on results from the successful randomized, multicenter, double-blind, placebo-controlled, phase III trial which assessed the efficacy and safety of aripiprazole lauroxil, where the drug demonstrated significant improvements in schizophrenia symptoms when compared to a placebo.
“We have designed aripiprazole lauroxil to be a differentiated treatment option for schizophrenia, with a ready-to-use format with multiple dosing options.”
Alkermes CEO Richard Pops said: “We have 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.”
The completion of the Phase III study, in which both doses of aripiprazole lauroxil tested, 441mg and 882mg administered once monthly, reached 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.
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