New labeling for Rexulti, a product of pharmaceutical companies Otsuka and Lundbeck, has been accepted for review by the U.S. Food and Drug Administration (FDA).
Rexulti was originally approved by the FDA on July 10, 2015, as a therapy for adults living with schizophrenia and as an adjunct treatment for adults who had been diagnosed with major depressive disorder (MDD). The expanded labeling would indicate the medication as a maintenance treatment for adults diagnosed with schizophrenia.
Statistics show more than two million Americans are living with schizophrenia. Approximately three quarters of those patients suffer relapses or worsening symptoms.
Before the supplemental New Drug Application (sNDA) was submitted for approval of the labeling change, Rexulti was the subject of a 52-week randomized withdrawal trial. Participants were adults aged 18 to 65 who had been diagnosed with schizophrenia.
The FDA is expected to complete its review of Rexulti's application on or before Sept. 23.
