HP-3070, the asenapine transdermal system, has a more predictable absorption profile and lower peak-to-trough fluctuations than sublingual asenapine, according to a poster presented at Psych Congress 2020.
Findings regarding the pharmacokinetics of the asenapine patch stemmed from 3 open-label, randomized phase 1 studies and 1double-blind, randomized, phase 3 study involving adults with schizophrenia.
In the phase 1 studies, the patch was dose-proportional, exhibited a Cmax/Cmin ratio of 1.5, and reached steady-state in approximately 72 hours. According to the poster abstract, area under the curve for 3.8 mg/24 hour and 7.6 mg/24 hour patch dosage strengths corresponded to sublingual asenapine 5 mg and 10 mg twice a day, respectively. Peak exposure with the patch, however, was significantly lower than with sublingual asenapine.
In the phase 3 study, 204 inpatients received 7.6 mg/24 hour patches, 204 inpatients received 3.8 mg/24 hour patches, and 206 inpatients received placebo. According to the poster, week 6 least-squares mean estimates of Positive and Negative Syndrome Scale score treatment comparison between HP-3070 and placebo for change from baseline were -4.8 and -6.6 for the 7.6 mg/24 hour patch and 3.8 mg/24 hour patch groups, respectively.
Systemic treatment-emergent adverse events with the asenapine patch were consistent with sublingual asenapine, according to the abstract. Treatment discontinuations due to application site reactions or skin disorders were infrequent.
The asenapine patch was efficacious, safe, and well-tolerated in adults with schizophrenia, researchers concluded, and provides a novel treatment option.
Hisamitsu Pharmaceutical Co. Inc. sponsored the study.
Walling D, Castelli M, Suzuki K, et al. Asenapine transdermal system: pharmacokinetics, efficacy, and safety profile for the first antipsychotic patch in the US. Poster presented at Psych Congress 2020; September 10-13, 2020; Virtual.