FDA Approves First Transdermal Patch for Treatment of Schizophrenia

The FDA has approved Secuado (asenapine; Noven) transdermal system for the treatment of adults with schizophrenia.

The Food and Drug Administration has approved Secuado (asenapine; Noven) transdermal system for the treatment of adults with schizophrenia.

Secuado is the first transdermal patch formulation indicated for patients with schizophrenia. The approval was supported by data from a 6-week, phase 3, double-blind, placebo-controlled, fixed-dose study in 616 adult patients with schizophrenia. Patients were randomized to receive Secuado 3.8mg/24 hours, 7.6mg/24 hours, or placebo. The primary efficacy end point was the change from baseline in the Positive and Negative Syndrome Scale (PANSS); the Clinical Global Impressions-Severity (CGI-S) rating scale, which measures a patient’s current illness states and overall clinical state, was designated a secondary outcome measure.

Results showed that both doses of Secuado were associated with statistically significant changes from baseline in total PANSS score compared with placebo at week 6 (placebo-subtracted difference: -6.6 [95% CI, -9.1 to -3.40] for Secuado 3.8mg/24 hours and -4.8 [95% CI, -8.06 to -1.64] for Secuado 7.6mg/24 hours). Additionally, Secuado-treated patients had a statistically significant improvement in CGI-S scores at both doses.

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With regards to safety, Secuado carries a Boxed Warning for increased mortality in elderly patients with dementia-related psychosis. It is also contraindicated in patients with severe hepatic impairment. The most common treatment-emergent adverse reactions were extrapyramidal disorder, application site reaction, and weight gain.

“As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” said Leslie Citrome, MD, MPH, Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College. “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.”

Secuado is supplied in 30 individually-packaged systems per carton in the following strengths: 3.8mg/24hr, 5.7mg/24hr, and 7.6mg/24hr.

Asenapine, an atypical antipsychotic, is also available in a sublingual tablet formulation. Based on the average exposure of asenapine, Secuado 3.8mg/24hours corresponds to 5mg twice daily of sublingual asenapine and Secuado 7.6mg/24hours corresponds to 10mg twice daily of sublingual asenapine.

For more information visit noven.com.

This article originally appeared on MPR