Allergan and Gedeon Richter have finally secured US approval for Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.
The drug is a potent dopamine D3/D2 receptor partial agonist atypical antipsychotic, initially turned down by the US Food and Drug Administration in 2013 with a request for more data, despite an acknowledgement at the time that it clearly demonstrated effectiveness.
US clearance was based on a package of clinical data garnered from more than 2,700 adults, showing that Vraylar improved symptoms of both schizophrenia and bipolar disorder with an acceptable tolerability profile. Data also showed a 55% reduction in risk of relapse of schizophrenia versus placebo.
The most commonly reported side effects in bipolar mania were extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness, while in schizophrenia they were extrapyramidal symptoms and akathisia. But, like all other FDA-approved drugs for these conditions, Vraylar carries a boxed warning alerting healthcare professionals of an increased risk of death in older people with dementia-related psychosis.
While there are already several antipsychotics on the market, “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,” noted Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Centre for Drug Evaluation and Research, commenting on Vraylar’s approval.