Noven Pharma Secuado Transdermal System Approved by FDA

Oct. 15, 2019, 1:08 PM UTC

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:
Bradley Davis in New York at bdavis299@bloomberg.net

To contact the editor responsible for this story:
Polina Noskova at pnoskova@bloomberg.net ...

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