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- 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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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