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Antipsychotic Patch Outperforms Placebo in Phase 3 Trial

May 21, 2019

SAN FRANCISCO—A once-daily asenapine patch is effective for the treatment of schizophrenia in adults, researchers reported during a poster session at the American Psychiatric Association’s annual meeting.

“Once approved, HP-3070 will be the first transdermal antipsychotic available in the United States, providing a novel treatment formulation,” wrote poster presenter Leslie L. Citrome, MD, MPH, and coauthors David Walling, PhD, Courtney Zeni, PhD, Marina Komaroff, DrPH, and Alexandra Park, in the poster abstract.

The poster reported secondary outcomes from a 6-week, double-blind, phase 3 study involving 616 adult inpatients with an acute exacerbation of schizophrenia.

Researchers randomized 206 patients to high-dose HP-3070 (equivalent to sublingual asenapine 10 mg twice a day), 204 patients to low-dose HP-3070 (equivalent to sublingual asenapine 5 mg twice a day), and 206 patients to placebo. HP-3070 met both the primary and key secondary endpoints, which involved change from baseline to week 6 on Positive and Negative Syndrome Scale (PANSS) total scores and the Clinical Global Impression–Severity of Illness Scale (CGI-S).

In this poster, which reported secondary efficacy outcomes and safety results, the antipsychotic patch demonstrated significant treatment response in both PANSS and CGI responder analyses.

At week 6, PANSS responder rates were 29.6% with high-dose HP-3070, 30.8% with low-dose HP-3070, and 18.7% for placebo, researchers reported. CGI responder rates were significantly higher with both low- and high-dose HP-3070, compared with placebo, at weeks 4, 5, and 6. CGI-responder rates were 43.3% with high-dose HP-3070, 49.8% with low-dose HP-3070, and 34% with placebo.

Treatment-emergent adverse events were mild to moderate in severity and consistent with sublingual asenapine, according to the poster abstract. Rates of application-site adverse events were 14.2% with the high-dose patch, 15.2% with the low-dose patch, and 4.4% for the placebo patch, and generally did not lead to treatment discontinuation.

This study was supported by Noven Pharmaceuticals, a wholly owned subsidiary of Hisamitsu Pharmaceutical Company.

—Jolynn Tumolo

Reference

“HP-3070 asenapine transdermal system in adults with schizophrenia: categorical response and clinical relevance as assessed in a phase 3 RCT.” Abstract presented at: the American Psychiatric Association Annual Meeting; May 21, 2019; San Francisco, CA.

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