In a post-hoc analysis of a phase III trial, once-daily asenapine transdermal system (HP-3070) was superior to placebo in reducing symptoms of hostility related to schizophrenia. HP-3070, a once-daily asenapine transdermal system, is the first transdermal patch FDA-approved for the treatment of adults with schizophrenia. The HP-3070 delivery system provides sustained concentrations during wear time (24 hours). Researchers analyzed data from the pivotal HP-3070 phase III randomized, double-blind, placebo-controlled study of adults with schizophrenia who were randomly selected to receive either HP-3070 7.6 mg/24h, HP-3070 3.8 mg/24h, or placebo for 6 weeks. The post-hoc analysis assessed a subset of patients (n = 442) )with a Positive and Negative Syndrome Scale (PANSS) hostility item score >1. The demographic characteristics were balanced between the two HP-3070 treatment groups (7.6 mg/24h (n = 151); and 3.8 mg/24h (n = 147)) and the placebo group (n = 144).

At week 6, significant improvement from baseline in PANNS hostility item scores were observed in both treatment groups relative to placebo. For patients on the 7.6 mg/24h dose, the least squares mean (LSM) changes from baseline was -0.4 (-0.6 to -0.2; P < 0.001) versus placebo at week 6. For patients on the 3.8 mg/24h dose, the LSM difference from placebo in change from baseline to week 6 was -0.3 point (-0.6 to -0.1; P < 0.01). Both treatment doses demonstrated significant improvement after 2-3 weeks of treatment, with the improvements sustained through week 6. After adjustment for a number of covariates, both patch doses significantly improved hostility in patients who had these symptoms at baseline. These covariates included baseline PANSS-positive symptoms and the presence of somnolence including hypersomnia, hypersomnolence, sedation, and akathisia. A once-daily transdermal formulation may address some of the challenges currently associated with sublingual and other oral treatments, as well as injectable formulations.

Reference:

Citrome L et al. J Clin Psychiatry. 2022;83(4). Abstract