FDA Approves Asenapine Patch to Treat Schizophrenia

The US Food and Drug Administration (FDA) has approved asenapine (SECUADO), the only transdermal patch to treat adults with schizophrenia.

The patch, developed by Noven Pharmaceuticals, is a once-daily transdermal drug delivery system (TDDS) that provides sustained concentrations during wear time of the atypical antipsychotic drug asenapine, commonly used to treat schizophrenia, to mitigate some of the challenges patients face.

“As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” Leslie Citrome, MD, clinical professor of Psychiatry and Behavioral Sciences at New York Medical College, said in a statement. “In addition to offering a new delivery option, transdermal patches can also provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilized.”

The patch was tested in an international, phase III, double-blind, placebo-controlled study, where the asenapine patch achieved the primary endpoint of statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale (PANSS) compared to placebo after 6 weeks.

Efficacy and safety was assessed during the 6-week study involving 616 adults living with schizophrenia.

SECUADO also demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, a secondary endpoint in the study.

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

While the FDA approved the treatment for patients with schizophrenia, they did issue a boxed warning that it should not be used to treat patients with dementia-related psychosis.