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news.Irish based biopharmaceutical company Alkermes has reported positive topline results from a randomized, double-blind, placebo-controlled Phase III clinical trial of its new, long-acting injectable antipsychotic agent aripiprazole lauroxil for the treatment of patients with schizophrenia.
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In the trial, about 623 patients were given once-monthly intramuscular injections of aripiprazole lauroxil 441mg, 882mg or placebo for 12 weeks.
Patients treated with either 441mg or 882mg of aripiprazole lauroxil showed significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) total scores at week 12, compared to placebo, which was the trial’s prespecified primary endpoint.
Based on the positive results from the Phase III trial, the company intends to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) in the third quarter of 2014.
The data from the full analysis set showed significant improvement in PANSS total scores from baseline in both aripiprazole lauroxil dose groups, relative to the placebo treatment group.
The company said that the trial also met the prespecified key secondary endpoint of improvement on the Clinical Global Impression – Improvement scale (CGI-I) versus placebo at week 12.
The most common adverse events observed in the Phase III trial were insomnia, akathisia and headache.
According to the company, all participants in the double-blind portion of the Phase III trial are eligible to continue in an open-label phase and receive aripiprazole lauroxil for an additional 12 months.
The objective of the trial’s extension phase is to evaluate the safety and long-term durability of effect of once-monthly aripiprazole lauroxil.