Noven Pharmaceuticals, a subsidiary of Hisamitsu Pharmaceutical, has received approval from the Food and Drug Administration (FDA) for Secuado (asenapine) transdermal system, a transdermal patch formulation for the treatment of adults with schizophrenia.
Leslie Citrome, clinical professor of psychiatry and behavioural sciences, New York Medical College, said: “As people living with schizophrenia cycle through treatments their therapeutic options narrow, leaving them and their caregivers looking for new treatment options. 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 utilised.”
The once-daily transdermal drug delivery system (TDDS) provides sustained concentrations during wear time (24 hours) of the atypical antipsychotic drug asenapine, a well-established treatment for schizophrenia. A transdermal patch may help to mitigate some of the challenges patients face with the management of their schizophrenia.
Dr. Naruhito Higo, chairman and chief executive officer, Noven Pharmaceuticals, said: “There is an enormous unmet need for new types of schizophrenia treatments, and Noven is committed to giving people living with this devastating disease and their family members new options that may help them effectively manage their symptoms. We commend the FDA on the approval of Secuado and look forward to bringing it to market in the U.S. as soon as possible so people living with schizophrenia have a transdermal delivery option for asenapine treatment.”
In the international, Phase three, double-blind, placebo-controlled study, Secuado achieved the primary endpoint of statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale (PANSS) compared to placebo at week six. Efficacy and safety were assessed during the six-week treatment period in 616 adults living with schizophrenia. Additionally, Secuado demonstrated statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores, the key secondary endpoint of the Phase three study.
The systemic safety profile of Secuado was consistent with what is known for sublingual asenapine. The most commonly observed adverse reactions were extrapyramidal disorder, application site reaction, and weight gain.