Cariprazine (Vraylar): New treatment for schizophrenia and bipolar disorder approved

 September 19, 2015 – The American Food and Drug Administration (FDA) just approved Cariprazine (Vraylar) capsules to treat schizophrenia and bipolar disorder in adults.

Schizophrenia is a chronic, severe and disabling brain disorder affecting about one percent of Americans. Typically, symptoms are first seen in adults younger than 30 years of age and include hearing voices or seeing things that are not there, believing other people are reading their minds or controlling their thoughts, and being New Schizo Isuspicious or withdrawn. Bipolar disorder, also known as manic-depressive illness, is another brain disorder that causes unusual shifts in mood, energy, activity levels and the ability to carry out day-to-day tasks. 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.

The efficacy of Cariprazine (Vraylar) in treating schizophrenia was demonstrated in 1,754 participants in three six-week clinical trials. In each of the trials, Cariprazine (Vraylar) was shown to reduce the symptoms of schizophrenia compared to placebo. The efficacy of Cariprazine (Vraylar) in treating bipolar disorder was shown in three three-week clinical trials of 1,037 participants. Cariprazine (Vraylar) was shown to reduce symptoms of bipolar disorder in each of the trials.

Boxed Warning: Cariprazine (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 Cariprazine (Vraylar) nor any other drug in this class is approved to treat such patients. The most common side effects reported by participants receiving Cariprazine (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 Cariprazine (Vraylar) for bipolar disorder were extrapyramidal symptoms, the urge to move (akathisia), indigestion (dyspepsia), vomiting, drowsiness (somnolence) and restlessness.


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thassodotcom Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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