A unit of Hisamitsu Pharmaceutical Co. Inc. said the U.S. Food and Drug Administration has approved Secuado, an over-the-skin patch for treating adults with schizophrenia.
The Japanese drugmaker Hisamitsu and its U.S. unit Noven Pharmaceuticals Inc. submitted an application to the FDA in December 2018 seeking approval of Secuado to treat symptoms of schizophrenia. Secuado is a transdermal drug delivery system worn for a period of 24 hours to deliver the antipsychotic drug asenapine. The therapy provides doctors a new delivery option and a nonintrusive, visual confirmation that a patient is taking their medication, according to Noven's Oct. 15 press release.
Schizophrenia is a chronic and severe mental disorder that affects how a person thinks, feels and behaves.
Secuado carries a boxed warning that the patch should not be used for treating people with dementia-related psychosis. Noven said medicines like Secuado can raise the risk of death in elderly people who have lost touch with reality due to confusion and memory loss.
The company said the medicine's approval was backed with data from a phase 3 trial that showed the drug improved the symptoms of schizophrenia.