FDA accepts Allergan’s Vraylar for review

Vraylar (cariprazine) was first approved by the US Food and Drug Administration in September 2015 for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder in adult patients.

Now the Dublin, Ireland-headquartered firm is trying to get the drug approved for include the treatment of depressive episodes associated with bipolar depression.

The sNDA is supported by data from three pivotal trials, in which Vraylar showed greater improvement than placebo for the change from baseline to week 6 on the Montgomery Asberg Depression Rating scale (MADRS) total score. Both cariprazine 1.5 mg and 3 mg demonstrated superiority to placebo in reducing depressive symptoms associated with bipolar I depression, the firm noted.

"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," said David Nicholson, chief R&D officer at Allergan. "These positive pivotal studies, demonstrated the efficacy and safety of Vraylar for the treatment of bipolar depression."

"Despite decades of development, bipolar depression remains difficult to treat. Importantly, bipolar I patients will need treatment for the full spectrum of of their disorder," said Gary Sachs, associate clinical professor of Psychiatry at Harvard Medical School.

"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."

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