FDA Clears First Transdermal Patch for Schizophrenia

Megan Brooks


October 15, 2019

The US Food and Drug Administration (FDA) has approved a transdermal patch formulation of the atypical antipsychotic asenapine (Secuado, Noven Pharmaceuticals) for the treatment of adults with schizophrenia, the company has announced.

The patch is applied once daily and provides sustained concentrations of asenapine over 24 hours.

"In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a nonintrusive, visual confirmation that a treatment is being utilized," Leslie Citrome, MD, clinical professor of psychiatry and behavioral sciences, New York Medical College, Valhalla, said in a company news release.

The efficacy and safety of transdermal asenapine were demonstrated over 6 weeks in an international, phase 3, double-blind, placebo-controlled study involving 616 adults with schizophrenia.

The primary endpoint of a statistically significant improvement from baseline in change of the total Positive and Negative Syndrome Scale (PANSS) compared with placebo at 6 weeks was achieved in the study.

Additionally, treatment with transdermal asenapine was associated with a significant improvement in Clinical Global Impression – Severity (CGI-S) score, the key secondary endpoint.

The systemic safety profile of transdermal asenapine was consistent with what is known for sublingual asenapine. The most common adverse reactions were extrapyramidal disorder, application site reaction, and weight gain.

The label has a boxed warning stating Secuado should not be used to treat patients with dementia-related psychosis. Full prescribing information is available online.

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