The FDA has accepted for review Otsuka and Lundbeck's supplemental new drug application for a label update to brexipiprazole.
The FDA has accepted for review Otsuka and Lundbeck’s supplemental new drug application for a label update to brexipiprazole (Rexulti).
Rexulti, which is currently indicated as a schizophrenia treatment and as adjunctive therapy to antidepressants for adults with major depressive disorder, could potentially be approved as maintenance treatment for schizophrenia.
The FDA is expected to take action on the labeling update application by September 23, 2016.
The application was accepted by the FDA based on data from a 52-week trial, involving patients who were stabilized on Rexulti and then randomized to receive either continued therapy with Rexulti or placebo.
In the trial, patients who took Rexulti demonstrated a significantly longer time to relapse than the placebo-treated patients.
The most common adverse effects associated with Rexulti include weight gain and akathisia.