US FDA approval to Secuado transdermal system of Noven Pharma for treating adults with schizophrenia

 

The US Food and Drug Administration (FDA) approval has been given to Secuado (asenapine) transdermal system which is the first-and-only transdermal patch formulation for the treatment of adults suffering from schizophrenia.

Sustained concentration is provided from the once-daily transdermal drug delivery system (TDDS) during wear time (24 hours) of the atypical antipsychotic drug asenapine which is a well-established treatment for schizophrenia.

Secuado achieved the primary endpoint in the international, phase 3, double-blind, placebo-controlled study which was statistically significant improvement from baseline in the change of the total positive and negative syndrome scale (PANSS) compared to placebo at week six. Safety and efficacy were evaluated during the six-week treatment period in 616 adults living with schizophrenia. Additionally, Secuado demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the phase 3 study.