Drug for Schizophrenia, Bipolar Disorder Gets FDA Approval

VRAYLAR (cariprazine), an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar disorder and for treatment of schizophrenia in adults.

Vraylar was shown to reduce schizophrenia symptoms better than placebo in 6-week trials involving a total of 1754 patients.

Vraylar appeared to improve symptoms for both bipolar disorder and schizophrenia patients.

Bipolar disorder, though, is categorized by unusual and dramatic shifts in behavior, teetering from manic to stoic, characterized by differences in mood, energy, physical activity, and the ability to carry out simple, daily tasks. Patients also showed improvement on the Clinical Global Impressions-Severity (CGI-S) rating scale, a secondary measure in the studies. Common adverse events in trial participants taking cariprazine for the treatment of schizophrenia include tremor, slurred speech, and involuntary muscle movements, while patients taking the drug for bipolar disorder most commonly reported extrapyramidal symptoms as well as the urge to move, indigestion, vomiting, drowsiness, and restlessness.

(dailyRx News) A newly approved medication could help some patients with serious mental health disorders.

Allergan and partner Gedeon Richter announced Thursday that the Food and Drug Administration had approved their Vraylar (caripazine) capsules.

“Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities”, Mitchell Mathis, MD, director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation and Research.

Cariprazine, to be sold as Vraylar, was once considered a potential blockbuster, with Richter setting its sales potential at as much as $2 billion a year.