Asenapine Approved as First Transdermal Patch for Treatment of Schizophrenia

Officials from the FDA have approved Noven Pharmaceuticals, Inc.’s asenapine (Secuado) transdermal system, which is the first-and-only transdermal patch for the treatment of adults with schizophrenia, according to the company.

Asenapine is a once-daily, transdermal drug delivery system that is indicated to help mitigate some of the challenges patients face with the management of their schizophrenia. The patch provides sustained concentrations during the suggested wear time of 24 hours.

The approval comes after an international, phase 3 study that included 616 adult participants with schizophrenia. The 6-week treatment period tested the safety and efficacy of asenapine, and the prescription demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S).

The most common adverse reactions seen through the study were extrapyramidal disorder, application site reaction, and weight gain.

Reference

U.S. FDA approves secuado (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia [news release]. Miami, FL & Jersey City, NJ; October 15, 2019: Noven Pharmaceuticals website. http://www.noven.com/PR101519.php. Accessed October 15, 2019.