Fanapt® Shown to be Effective in Bipolar I Disorder in Phase III Clinical Study

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[{"type":"text","content":"Supplemental New Drug Application (sNDA) planned for 2023WASHINGTON, Dec. 19, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported positive results in a Phase III clinical study of Fanapt® (iloperidone tablets), a novel atypical antipsychotic, in the treatment of acute manic and mixed episodes associated with bipolar I disorder in adults. Fanapt® is currently approved by the FDA for the treatment of schizophrenia in adults.\nIn clinical study VP-VYV-683-3201 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 in a 1:1 ratio at clinical sites in the United States, Bulgaria and Poland. The primary endpoint measured in Week 4 of treatment was assessed by the Young Mania Rating Scale (YMRS), a rating scale of clinical severity in the core symptoms of mania. At the end of the study (Week 4), Fanapt® treated patients showed a larger improvement than placebo treated patients, and this difference was highly statistically significant (p=0.000008).\nYMRS was assessed at the end of Weeks 1, 2, 3 and 4. Statistically significant benefit in the Fanapt® group over placebo was observed as early as the Week 2 assessment. Consistent with the total YMRS score, the individual YMRS subscale items also showed improvement in the Fanapt® group versus the placebo group over the course of the 4-week study. Other outcomes, such as Clinician Global Impression of Severity (CGI-S) and Clinician Global Impression of Change (CGI-C), also achieved statistical significance (p=0.0005 and p=0.0002, respectively).\n\"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 H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. \"We look forward to submitting our supplemental New Drug Application to the FDA and expanding the Fanapt franchise.\"\nBipolar disorder is highly prevalent in the United States, estimated to affect 2.8%1, of the U.S. adult population, a number approximately up to ten times higher than the estimated prevalence of schizophrenia2,3.\nVanda plans to submit this pivotal study data of Fanapt® for the treatm...

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