Noven Pharmaceuticals, a wholly-owned subsidiary of Hisamitsu Pharmaceutical, announced it had received approval from the US Food and Drug Administration (FDA) for Secuado (asenapine), as the only transdermal patch formulation for the treatment of schizophrenia in adults.
According to the company, the patch is attached on the skin once daily and kept for 24 hours. During wear time, it releases sustained concentrations of the atypical antipsychotic drug asenapine, which is a ‘well-established’ treatment for schizophrenia.
The transdermal drug delivery method answers an ‘enormous’ unmet need for new types of schizophrenia treatments to help patients effectively manage their symptoms, according to Naruhito Higo, Noven’s CEO.
“As people living with schizophrenia cycle through treatments, their therapeutic options narrow, leaving them and their caregivers looking for new treatment options,” Leslie Citrome, clinical professor of psychiatry and behavioral sciences at New York Medical College, commented on his side.
Moreover, Citrome stated that the transdermal patches, further to offering an alternative delivery option, provide caretakers and healthcare providers with a non-intrusive, visual confirmation that a treatment is being utilized.
The FDA approval of Secuado came after the treatment met its primary endpoint of improvement and demonstrated safe and efficacious results in 616 adults with schizophrenia, during Phase III clinical studies.