“Despite the variety of treatments available for the millions living with bipolar I disorder and schizophrenia, unmet needs remain and we are proud to offer an additional option to help patients manage their symptoms”.
Advertisement
Allergan plc (AGN) and Gedeon Richter Plc. announced that the U.S. Food and Drug Administration has approved VRAYLAR or cariprazine capsules, an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.
Vraylar is manufactured by Forest Laboratories. In the schizophrenia trials, the change was measured by Positive and Negative Syndrome Scale (PANSS) total scores. VRAYLAR also demonstrated efficacy as measured by the Clinical Global Impressions-Severity (CGI-S) rating scale, the secondary efficacy endpoints for both conditions.
Ultimately, a handful of six-week clinical trials totaling more than 2,700 patients showed that the drug reduced symptoms of each condition compared with placebo (there were 1,754 patients in three schizophrenia trials and 1,037 patients in three bipolar disorder trials). The same was true for the bipolar disorder trials, with the addition of akathisia, dyspepsia, vomiting, drowsiness, and restlessness.
Bipolar disorder affects ~2.6M American adults.
Like other antipsychotics, cariprazine will come with a boxed warning about increased risk of death in older people with dementia-related psychosis.
In the new drug news release published by the FDA, Mitchell Mathis, M.D., director of the Division of Psychiatry Products noted that, “schizophrenia and bipolar disorder can be disabling and can greatly interfere with day-to-day activities”.
Advertisement
Cariprazine, to be sold as Vraylar, was once considered a potential blockbuster, with Richter setting its sales potential at as much as $2 billion a year.
