The wholly-owned subsidiary of Hisamitsu Pharmaceutical Co. says FDA approves Secuado transdermal system to treat adults with schizophrenia.
- In Phase 3 study, SECUADO achieves primary endpoint of statistically significant improvement from baseline compared to placebo at week six: company
- Efficacy and safety assessed during six-week treatment period
- Includes FDA boxed warning for elderly patients with dementia-related psychosis
- Also demonstrates statistically significant improvement in CGI-S scores, the key secondary endpoint of the Phase 3 study
To contact the reporter on this story:
To contact the editor responsible for this story:
Learn more about Bloomberg Law or Log In to keep reading:
Learn About Bloomberg Law
AI-powered legal analytics, workflow tools and premium legal & business news.
Already a subscriber?
Log in to keep reading or access research tools.