Secuado FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 27, 2020.
Secuado (asenapine) is a transdermal atypical antipsychotic formulation indicated for the treatment of adults with schizophrenia.
- Secuado is the first-and-only schizophrenia treatment approved as a transdermal patch formulation.
- Asenapine, the atypical antipsychotic contained in Secuado, is also available as a sublingual tablet formulation under the brand name Saphris.
- Secuado patches are applied to the skin (hip, abdomen, upper arm, or upper back area) every 24 hours.
- The efficacy of Secuado was established on the basis of efficacy data from trials with sublingual asenapine, and the results of a 6-week clinical study that demonstrated statistical superiority to placebo in Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impressions-Severity (CGI-S) scores. The safety profile of Secuado was consistent with data from trials with sublingual asenapine.
- The Secuado product label carries a boxed warning advising healthcare providers of the increased risk of death in elderly people with dementia-related psychosis. Common side effects include extrapyramidal disorder, application site reaction, and weight gain.
Development timeline for Secuado
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