FDA approves Cariprazine to treat schizophrenia and bipolar disorder

By Caribbean Medical News Staff
The Food and Drug Administration (FDA) has approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults. Mitchell Mathis, M.D, who is the Director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research said: “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.”
Described as a chronic, severe and disabling brain disorder, Schizophrenia affects about one percent of Americans. Symptoms are usually seen in adults younger than 30 years of age. Some symptoms may include: believing other people are reading their minds or controlling their thoughts, being suspicious or withdrawn and hearing voices or seeing things that are not there.
Also known as ‘manic-depressive illness’, Bipolar disorder is another brain condition that causes strange shifts in personality, energy, activity levels and the ability to carry out daily tasks. Some symptoms of bipolar disorder include: irritability, irregular periods of depression and elevation (mood), increased activity and restlessness, racing thoughts, talking fast, impulsive behaviour and a decreased need for rest.
In each of the trials, Vraylar was shown to decrease the symptoms of schizophrenia compared to placebos. The efficacy of Vraylar in treating schizophrenia was proven in 1,754 participants in three six-week clinical trials.
Tests of Vraylar in treating bipolar disorder were conducted in three three-week clinical trials of 1,037 participants. Vraylar also proved effective in lessening symptoms of bipolar disorder in each of the trials.
Some of the 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. Whereas, 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.

Leave a Comment

Security Question * Time limit is exhausted. Please reload CAPTCHA.

Powered by WordPress