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# Noven’s Schizophrenia Transdermal Patch Approved
- URL: https://www.fdaweb.com/novens-schizophrenia-transdermal-patch-approved/
- Published: 2019-10-15T12:00:00.000Z
- Updated: 2026-09-15T01:56:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145249

FDA has approved a Noven Pharmaceuticals NDA for Secuado (asenapine) transdermal system for treating adults with schizophrenia. Approval is based on data from a Phase 3 placebo-controlled study in which Secuado achieved the primary endpoint of statistically significant improvement from baseline compared to placebo at week six, according to the company. Additionally, it demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, a key secondary endpoint, it says.

Noven says Secuado’s systemic safety profile was consistent with what is known for sublingual asenapine. The most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain.