- Vanda Pharmaceuticals Inc (NASDAQ:VNDA) reported results from a Phase 3 study of Fanapt (iloperidone tablets), a novel atypical antipsychotic, in acute manic and mixed episodes associated with bipolar I disorder in adults.
- Fanapt is currently approved by the FDA for schizophrenia in adults.
- In the 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 a placebo.
- 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, which was highly statistically significant (p=0.000008).
- A 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 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).
- Vanda plans to submit the data of Fanapt for acute manic and mixed episodes associated with bipolar I disorder in adults in a supplemental New Drug Application (sNDA) in 2023.
- Price Action: VNDA shares are up 1.28% at $7.14 on the last check Monday.
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