Allergan’s Vraylartm (cariprazine), a once-daily oral atypical antipsychotic, is now available by prescription in pharmacies throughout the U.S.
As Allergan noted, Vraylar was approved by the U.S. Food and Drug Administration in September 2015 for the treatment of acute manic or mixed episodes of bipolar I disorder and schizophrenia in adults.
“We are excited that Vraylar is now available to the millions of people living with bipolar I disorder and schizophrenia,” said David Nicholson, President and EVP, Global R&D at Allergan. “This launch reinforces Allergan’s rich heritage in mental health and our ongoing commitment to developing treatment options that address unmet needs for people who are affected by these serious conditions.”
Allergan explained that bipolar I disorder, also known as manic-depressive illness, and schizophrenia are among the most challenging mental health disorders to manage, and together affect approximately 8.5 million adults in the United States. Treatment for both illnesses is often complicated by high rates of relapse and a high degree of variability in disease course and severity, as well as patient symptoms and response to treatment.
“The important differences in how patients with bipolar I disorder and schizophrenia respond to treatment underscore the need for more treatment options for these serious illnesses ,” said Gary Sachs, MD, Founding Director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical school. “The availability of Vraylar gives physicians access to a new treatment option that I think will be appealing to patients who are living with these often devastating conditions.”
The safety and efficacy of Vraylar was studied in a clinical trial program which included more than 2,700 adult patients suffering from schizophrenia or bipolar mania. Vraylar will be commercially available in 30 count bottles in 1.5mg, 3mg, 4.5mg and 6mg and a 7 count mixed blister pack (one 1.5mg and six 3mg tablets).
Tagovi: Allergan Vraylartm cariprazine David Nicholson Gary Sachs