The US Food and Drug Administration (FDA) has approved a transdermal patch formulation of asenapine (Secuado) as the first patch for the treatment of adults with schizophrenia, Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., announced.
The once-daily patch provides sustained concentrations of the atypical antipsychotic asenapine during its 24-hour wear time. Asenapine is a well-established treatment for schizophrenia, and the patch delivery system "may help to mitigate some of the challenges patients face with the management of their schizophrenia," the company said in a statement.
Secuado achieved the primary endpoint of statistically significant improvement in the total Positive and Negative Syndrome Scale (PANSS) score, compared with placebo, from baseline to week 6 in an international Phase 3, double-blind study, the company said. It also demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the study.
“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, Valhalla. “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.”
The Noven statement described with systemic safety profile of Secuado as consistent with what is known for sublingual asenapine, with extrapyramidal disorder, application site reaction, and weight gain as the most common site reactions.
See the full prescribing information, including a Boxed Warning, here.
US FDA approves Secuado (asenapine) transdermal system, the first-and-only transdermal patch for the treatment of adults with schizophrenia [press release]. Miami, FL: Noven Pharmaceuticals; October 15, 2019.