VRAYLAR has already been approved by the FDA for the treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Now the FDA has accepted Allergan’s request to review their supplemental New Drug Application for VRAYLAR, to expand the indication to include the treatment of depressive episodes associated with bipolar I disorder in adults. In the RGH-MD-53, RGH-MD-54 and RGH-MD-56 trials, cariprazine 1.5 mg and 3 mg showed superiority to placebo in reducing depressive symptoms associated with bipolar I depression, and the drug showed more improvement than placebo for the change from baseline to week 6 on the Montgomery Asberg Depression Rating scale total score.
Gary Sachs, MD, Associate Clinical Professor of Psychiatry at Harvard Medical School, said: "Despite decades of development, bipolar depression remains difficult to treat. Importantly, bipolar I patients will need treatment for the full spectrum of their disorder. If approved for bipolar depression, cariprazine would be the first and only partial agonist with proven efficacy for both the manic and depressive symptoms of bipolar I disorder. That is very encouraging news for patients, their families, and the psychiatry community."
“FDA accepts sNDA for cariprazine for bipolar depression.“
David Nicholson, Chief Research & Development Officer at Allergan, said: "This sNDA filing provides an important step towards the availability of a potential treatment option for the approximately 5 million patients suffering with bipolar I depression. These positive pivotal studies, demonstrated the efficacy and safety of VRAYLAR for the treatment of bipolar depression. VRAYLAR is the flagship product of our Psychiatry portfolio and demonstrates Allergan's commitment to the mental health community."