Bristol-Myers Squibb and Otsuka Pharmaceutical file Abilify with regulators

Bristol-Myers Squibb and Otsuka Pharmaceutical have announced the filing of Abilify (aripiprazole) with the regulatory authorities as a treatment for major depressive disorder patients administered as an adjunctive to therapy with antidepressants.

The companies report that the compound has been given a priority review by the US Food and Drug Administration (FDA) as a supplemental new drug application (sNDA), which denotes that, if approved, the compound will offer a significant patient benefit compared to existing products and therapies for a disease.

According to FDA targets, the body aims to complete its review of the compound within six months of its filing.

“This sNDA is based on data from two six-week, double-blind, randomized, placebo-controlled, multi-centre trials evaluating the use of adjunctive Abilify in adult patients with a primary diagnosis of major depressive disorder,” the company reports.

It adds that these patients have also displayed an insufficient response to monotherapy with one or more antidepressant treatments.

In December 2006, Bristol-Myers Squibb announced the results of a trial of Abilify as long-term maintenance therapy for bipolar I disorder patients.

The compound exhibited efficacy in producing a delayed relapse time in those individuals who have recently experienced a manic or mixed episode.