October 15, 2019

The U.S. FDA has approved Secuado® (asenapine) transdermal patch, manufactured by Noven Pharmaceuticals, as the first and only transdermal patch indicated to treat schizophrenia in adult patients.

Schizophrenia is a chronic, severe behavioral health disorder that affects approximately 3.5 million individuals in the U.S. The majority of patients (75%) develop symptoms between 16 and 25 years of age. Symptoms may include hallucinations, thought and movement disorders, loss of pleasure in everyday life, reductions in speech or expression, and difficulty beginning and sustaining activities. Schizophrenia can also lead to difficulties with focus, understanding, and decision-making. Although the exact cause of the disorder is unknown, genetics, environmental factors, and differences in brain structure and chemistry are all believed to play a role.

In a clinical study, patients who received Secuado achieved statistically significant improvement from baseline as measured by the total Positive and Negative Syndrome Scale (PANSS) compared to placebo by the sixth week of treatment. Patients also experienced statistically significant improvement in Clinical Global Impression-Severity (CGI-S) scores. PANSS is a standard measurement of symptom severity in patients who have schizophrenia. CGI-S scores are determined by clinicians who rate the severity of a patient’s illness relative to their past experience with individuals who have the same diagnosis.

Recommended dosing with Secuado is one 3.8mg transdermal patch applied to the hip, abdomen, upper arm, or upper back area once every 24 hours. If needed, the dose can be increased after one week to one 5.7mg patch every 24 hours, or one 7.6mg patch every 24 hours. A black box warning cautions that antipsychotic drugs like Secuado can increase the risk of death in elderly patients who have dementia-related psychosis. Secuado should not be used to treat dementia-related psychosis.

Noven has not yet announced launch or pricing plans.

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