FDA Approves First Transdermal Patch for Schizophrenia
The US Food and Drug Administration (FDA) has approved a transdermal patch formulation of asenapine (Secuado) as the first patch for the treatment of adults with schizophrenia, Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., announced.
The once-daily patch provides sustained concentrations of the atypical antipsychotic asenapine during its 24-hour wear time. Asenapine is a a well-established treatment for schizophrenia, and the patch delivery system “may help to mitigate some of the challenges patients face with the management of their schizophrenia,” the company said in a statement.
Secuado achieved the primary endpoint of statistically significant improvement in the total Positive and Negative Syndrome Scale (PANSS) score, compared with placebo, from baseline to week 6 in an international Phase 3, double-blind study, the company said. It also demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the study.
