H. Lundbeck and Otsuka Pharmaceutical Development & Commercialization have reported that the U.S. Food and Drug Administration has approved the update to the Rexulti label.
The label will now show clinical data for the maintenance treatment of schizophrenia.
“There are approximately 2.4 million adults in the U.S. with schizophrenia and 75 percent of patients experience relapses where their symptoms return or worsen,” Hofstra Northwell School of Medicine professor of psychiatry Dr. Christoph Correll said. “These data, as included in the product labeling, confirm the utility of Rexulti in the maintenance treatment of patients with schizophrenia in order to help delay the time to relapse, giving patients and their physicians new data to consider when selecting an antipsychotic.”
The FDA approved the changes to the label due to the results from a clinical trial involving adults ages 18 to 65 who have schizophrenia. Rexulti’s safety and effectiveness as a treatment for schizophrenia in adults showed that it stabilized symptoms over a 12-week period.