The U.S. Food and Drug Administration (FDA) has given the green light to a new drug intended to treat mental illness in adults.
The FDA released last Thursday stated that Allergan and Gedeon Richter's cariprazine (Vraylar) has been approved for the treatment of schizophrenia and bipolar disorder.
It is a once daily capsule formulation belonging to the class of drugs known as atypical antipsychotics that have been clinically evaluated in two separate trials for both mental disorders.
The approval given by the regulatory board was based on the results from three trials conducted on patients with bipolar for three weeks and three trials conducted on schizophrenia patients for six weeks.
The efficacy of the drug was seen in the trials involving over 2,700 participants; 1,037 of them belonged to the bipolar disorder trials while 1,754 participated in the schizophrenia trials.
In both trials, Vrayler was seen to reduce the symptoms of the mental disorders.
According to the FDA release, the most common side effects experienced by those from the bipolar disorder trial include indigestion, vomiting, restlessness, and drowsiness. Meanwhile, those from the schizophrenia trial experienced tremors, involuntary muscle movements, and slurred speech.
Just like any other antipsychotic medications intended for bipolar disorder and schizophrenia, Vraylar also comes with a boxed warning stating that there is an increased risk of death if it is used in elderly patients that suffer from dementia-related psychosis.
About one percent of people in the United States suffer from schizophrenia, the FDA noted. Symptoms of the disorder usually start to show up in adults before they reach the age of 30.
Some of the symptoms include hearing voices or seeing things that aren't there.
Bipolar disorder, on the other hand, is characterized by restlessness and experiencing episodes of mania and depression alternately. Also known as manic-depression, the disorder affects an estimated 5.7 million American adults, which translates to 2.5 percent of people over 18, every year.
