Industry Bulletins | March 21, 2017
FDA Accepts Supplemental New Drug Application For Vraylar For Schizophrenia
The federal Food and Drug Administration (FDA) has accepted Allergen's supplemental new drug application (sNDA) for Vraylar (cariprazine) as a maintenance treatment for schizophrenia. According to studies, those who take the drug for schizophrenia maintenance were less likely to relapse than those who received a placebo (24.8% vs. 47.5%). Vraylar is currently approved for the treatment of bipolar I and schizophrenia.
Relapse data was obtained through a multinational, random, double-blind, placebo-controlled parallel group study of adults with the disorder. A 20-week, open-level phase-in offered participants 3, 6 or 9 milligrams of Vraylar . . .