Noven Pharmaceuticals announced the availability of Secuado® (asenapine) transdermal system for the treatment of adults with schizophrenia.

Secuado is a once-daily transdermal patch formulation of asenapine that provides sustained concentrations over 24 hours. The patch is applied to clean, dry and intact skin at one of the following sites: upper arm/back, abdomen, or hip. Patients should select a different application site each day to minimize skin reactions. Showering with the patch is permitted but swimming and taking a bath has not been evaluated.

The approval was supported by data from a 6-week, phase 3, double-blind, placebo-controlled, fixed-dose study that compared the efficacy and safety of Secuado 3.8mg/24 hours and 7.6mg/24 hours to placebo in 616 adult patients with schizophrenia. Results showed that both doses of Secuado were statistically superior to placebo for both Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impressions-Severity (CGI-S) scores. 

With regard 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 include extrapyramidal disorder, application site reaction, and weight gain.

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Secuado is supplied as 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.

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