US FDA Approves First Transdermal Formulation of an Antipsychotic
October 16, 2019   

The US Food and Drug Administration (FDA) has approved a transdermal formulation of asenapine for the treatment of adults with schizophrenia. The transdermal patch, marketed as SECUADO®, is a once-daily delivery system that provides sustained concentrations during wear time (24 hours). Its approval is based on an international Phase 3, 6-week, double-blind, placebo-controlled study in which SECUADO was superior to placebo on the primary endpoint of reducing the total Positive and Negative Syndrome Scale (PANSS) score from baseline. The safety profile was consistent with that seen with the sublingual formulation, which until now has been the only formulation option available for asenapine.

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