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Secuado FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 27, 2020.

FDA Approved: Yes (First approved October 11, 2019)
Brand name: Secuado
Generic name: asenapine
Dosage form: Transdermal System
Company: Noven Pharmaceuticals, Inc.
Treatment for: Schizophrenia

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

Oct 15, 2019Approval FDA Approves Secuado (asenapine) Transdermal System for the Treatment of Adults with Schizophrenia
Dec 17, 2018Notification of a New Drug Application for HP-3070 (Transdermal Patch for the Treatment of Schizophrenia) in the U.S.
Jan 31, 2018Notification of the Results of the Phase III Clinical Study of HP-3070 (Transdermal Patch for the Treatment of Schizophrenia) in the U.S.

Further information

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