Schizophrenia Medication Seeks Label Update for Maintenance Treatment

The FDA has accepted Allergan’s supplemental new drug application (sNDA) for Vraylar (cariprazine).

The sNDA seeks to expand the product’s label to include the addition of new clinical data that evaluate the efficacy of Vraylar as a maintenance treatment for adults with schizophrenia. The data are from a phase 3 multinational, randomized study of the drug in adults with schizophrenia. Study researchers reported that cariprazine significantly delayed the time to relapse compared to a placebo.

“Most patients with schizophrenia are at very high risk of relapse in the absence of antipsychotic treatment,” Herbert Meltzer, MD, Professor of Psychiatry at Northwestern Feinberg School of Medicine, said in a press release. “Without maintenance treatment, 60-70% of patients relapse within 1 year, and almost 90% relapse within 2 years. These new data show that Vraylar may be a treatment option for the maintenance treatment of schizophrenia.”

The FDA approved cariprazine in September 2015 for the acute treatment of manic or mixed episodes of bipolar type 1 disorder and the treatment of schizophrenia in adults.

Reference

FDA Accepts Supplemental New Drug Application (sNDA) for Vraylar (cariprazine) [news release]. Dublin. Allergan’s website. https://www.allergan.com/News/News/Thomson-Reuters/FDA-Accepts-Supplemental-New-Drug-Application-(3). Accessed Mar. 8, 2017.