The approval was based on a set of six controlled clinical trials that included over 2,700 adults with bipolar disorder or schizophrenia. Vraylar was shown to reduce the symptoms of both disorders compared with placebo, and was fairly well tolerated, with the most commonly reported adverse reactions being extrapyramidal symptoms and restlessness (akathisia).
Vraylar is one of the first FDA-approved antipsychotics that has demonstrated efficacy in alleviating negative symptoms of schizophrenia such as a lack of motivation or desire.
It is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient's individual needs,” Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Centre for Drug Evaluation and Research, said in an FDA release.
Gedeon Richter Plc. had previously submitted an approval request for this drug in 2013 that was turned down by the FDA, with the agency acknowledging the drug’s effectiveness but requesting more data, particularly information on optimal dosing for this oral, once-daily drug.
According to a release by Gedeon Richter and Allergan, the recommended dose range for Vraylar for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder is 3 to 6 mg/day and 1.5 to 6 mg/day for the treatment of schizophrenia in adults.
To learn more about cariprazine, see the Psychiatric News article “As FDA Decision Nears, Cariprazine Collects More Proof of Efficacy.
(Image: Hurst Photo/Shutterstock)