Allergan has just announced that their product, Vraylar has been approved by the U.S. Food and Drug Administration (FDA) for use to treat manic or mixed episodes of bipolar 1 and schizophrenia mental disorders in adults.
The approval was given after Vraylar passed the three controlled clinical trials in adults with schizophrenia and bipolar 1 lasting three weeks each, and three more placebo-controlled trials in schizophrenic adults for six weeks each. In both bipolar and schizophrenia patients, Vraylar was able to significantly improve the condition of those who took the medication over those who did not or were given placebos.
Most common reactions reportedly caused by schizophrenic patients taking Vraylar were the triad of tremors, slurring of speech and involuntary muscle spasms collectively called extrapyramidal symptoms. For bipolar patients, common side effects were, aside from the extrapyramidal symptoms, indigestion, agitation and drowsiness. The combined number of participants for all trials was more than 2,700 volunteers.
"Schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities," said Dr. Mitchell Mathis, Director of the Division of Psychiatry Products at FDA's Center for Drug Evaluation and Research.
He added that variety in treatment options should be available so that care plans can be modified to suit individual patient's needs.
David Nicholson, President of the Global R&D brands of Allergan, said that the company is pleased with the FDA's approval of Vraylar, as it represents the importance of making new treatment options for schizophrenic and bipolar patients available.
"This approval reinforces our deep commitment to the mental health community, as we continue to build our robust CNS portfolio." Nicholson said.
Vraylar, or cariprazine, is a partial agonist of D2 and D3 dopamine and 5-HT1A serotonin receptors. Its higher affinity for D2 and D3 receptors is especially effective in treating schizophrenia symbols while reducing risk for side effects associated with other anti-psychotic drugs. It is to be taken once a day orally at recommended dosage of 3 to 6 mg a day for bipolar manic or mixed episodes and 1.5 to 6 mg a day for schizophrenia.
Vraylar was discovered and co-created by Gedeon Richter Plc. It is now being distributed by Allergan, formerly Actavis, in Canada and the U.S. Research is now being carried out if Vraylar can also be used to treat depressive bipolar episodes as well as major depressive disorder in adults. Along with other antipsychotics, Vraylar is not to be used to treat psychosis caused by dementia.