Vanda Pharma: Phase III Study Shows Potential Of Fanapt In Treating Bipolar I Disorder

(RTTNews) - Vanda Pharmaceuticals Inc. (VNDA) reported positive results in a Phase III study of Fanapt in the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults. In the study, approximately 400 volunteers with a history of bipolar I disorder suffering from a current episode of mania were randomized to receive either Fanapt or placebo. At the end of the study, Fanapt treated patients showed a larger improvement than placebo treated patients, and this difference was highly statistically significant, the company noted.

"The robust clinical trial results we report today demonstrate the potential to extend the utility of Fanapt into treating adult patients with bipolar I disorder, in addition to the already marketed indication of schizophrenia," said Mihael Polymeropoulos, Vanda's CEO.

The company plans to submit this study data of Fanapt for the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults in a supplemental New Drug Application in 2023.

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