Richter, Allergan announce positive results for cariprazine
Image by gedeonrichter.com
Hungarian drugmaker Gedeon Richter and its Irish peer Allergan on Tuesday announced positive topline results in a Phase III clinical trial of cariprazine for treatment of bipolar I depression, according to a press release sent to the Budapest Business Journal.
Allergan plans to include data from all three trials of cariprazine for the treatment of bipolar I depression in a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in the second half of 2018.
Cariprazine is currently approved in the U.S. under the brand name Vraylar for treatment of schizophrenia in adults, and acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
"We are very pleased with the results of our third pivotal study, which reinforce the wealth of data supporting cariprazine as a potential treatment in adults with bipolar depression," said David Nicholson, chief R&D officer at Allergan. "Bipolar depression is often difficult to treat and can be extremely debilitating for patients. At Allergan, we are committed to developing treatments that address unmet needs facing people living with mental illness, and are looking forward to submitting an sNDA for cariprazine for patients suffering with bipolar I depression."
"Todayʼs positive results provide further support for the therapeutic value of cariprazine, one of our flagship products. We are encouraged by the findings, which mark a major step forward in making this promising treatment option available for patients suffering from bipolar depression," added Dr. István Greiner, research director of Gedeon Richter.
Cariprazine was discovered and co-developed by Gedeon Richter and is licensed by Allergan in the U.S. and Canada. For more than a decade both companies have conducted over 20 clinical trials enrolling thousands of patients worldwide to evaluate the efficacy and safety of cariprazine for patients suffering from a broad range of mental health illnesses, said the press release.
Richter booked HUF 14.0 billion from sales of cariprazine last year, making it the companyʼs sixth best-selling product, according to state news agency MTI.
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