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

According to results from a phase 3 study, Iloperidone was linked to significant improvement in adults with bipolar I disorder.

In 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).

YMRS 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).