On Thursday, the U.S. Food and Drug Administration (FDA) approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults. The new treatment was approved after research on 2,791 patients showed that Vraylar reduced the symptoms of both bipolar disorder and schizophrenia symptoms, in separate studies.
Vraylar is manufactured by Forest Laboratories.
Forest said that the FDA approval is based on the results of three 3-week controlled trials in adults with manic or mixed episodes of bipolar I disorder and three 6-week placebo-controlled trials in adults with schizophrenia.
The research studies showed that patients who took cariprazine demonstrated improvement compared to placebo as measured by Young Mania Rating Scale (YMRS) total scores in patients with bipolar mania in the bipolar studies. In the schizophrenia trials, the change was measured by Positive and Negative Syndrome Scale (PANSS) total scores. Patients also showed improvement on the Clinical Global Impressions-Severity (CGI-S) rating scale, a secondary measure in the studies.
According to the FDA, the most common side effects reported by participants receiving Vraylar in the clinical trials for schizophrenia were extrapyramidal symptoms, such as tremor, slurred speech, and involuntary muscle movements.
The most common side effects reported by trial participants receiving Vraylar for bipolar disorder were extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence), and restlessness.
Bipolar disorder (sometimes known as manic-depression) is a mental disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. The cause of bipolar disorder is unknown. The symptoms of bipolar disorder include alternating periods of depression and high, irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.
Schizophrenia is a chronic, severe, and disabling mental disorder whose cause is unknown. Symptoms are usually first seen in young adults during their 20’s and include hearing voices or seeing things that are not there, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.
Vraylar and all other FDA-approved drugs used to treat schizophrenia and bipolar disorder have a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs in older people with dementia-related psychosis. Neither Vraylar nor any other drug in this class is approved to treat such patients.
In the new drug news release published by the FDA, Mitchell Mathis, M.D., director of the Division of Psychiatry Products noted that, “schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities. 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.”
“We are pleased with the FDA approval of Vraylar, which represents an important new treatment option for adults living with bipolar I disorder and schizophrenia to help address the unmet medical needs of people with these complex conditions,” said David Nicholson, Executive Vice President and President of Global R&D brands of Allergan, Forest Laboratories’ parent company.
Source: FDA & Others