Noven Pharmaceuticals (a subsidiary of Hisamitsu Pharmaceutical) has announced that its Secuado (asenapine) has been approved by the US Food and Drug Administration (FDA) and will be available on the US market for adult schizophrenia patients.
Secuado is the first and only transdermal patch formulation to be approved for treating schizophrenia. Unlike treatments currently available on the market, Secuado’s patch formulation makes it easier for caregivers and healthcare providers to administer.
The patch has the potential to be commercially successful because it will significantly simplify managing symptoms in a non-invasive formulation.
Secuado is administered once per day via a transdermal drug delivery system that provides sustained concentrations of antipsychotic asenapine during the recommended wear time of 24 hours. Clinical studies evaluating the safety and efficacy of Secuado found that the product led to statistically significant improvement based on the Clinical Global Impression-Severity scale. However, clinical studies have also shown adverse effects such as extrapyramidal disorder, application site reactions, and weight gain.
The schizophrenia market is known for its high levels of clinical need. Secuado offers an alternative to the use of intrusive treatments to manage symptoms and gives a visual confirmation that the treatment is being used. Although Secuado has received FDA approval, it will need to be evaluated by caregivers and healthcare providers before its gains widespread use, so the treatment may still face a slow uptake in the schizophrenia market.