Asenapine Transdermal Patches Effective for Reducing Hostility in Patients With Schizophrenia

HP-3070 (asenapine transdermal system), which was approved by the US Food and Drug Administration (FDA) as a 24-hour patch treatment for schizophrenia in adults, was shown to be more effective than placebo for reducing hostility in adult patients. Researchers presented results of an ad hoc analysis of their phase 3 trial at the 2021 Psych Congress, conducted virtually and in person in San Antonio, Texas, from October 29th through November 1st.

Patients included in the trial (n=616) were experiencing exacerbated schizophrenia and had scores of at least 4 on the Clinical Global Impression-Severity of Illness (CGI-S) scale and at least 80 on the Positive and Negative Syndrome Scale (PANSS). They had scores of at least 4 and at least 2 for the following PANSS measures: conceptual disorganization, delusions, hallucinatory behavior, and unusual thought content.

The study participants underwent patch treatment with either HP-3070 7.6 mg/24 h (n=206), HP-3070 3.8 mg/ 24 h (n=204), or placebo (n=206) for 6 weeks.

The researchers analyzed PANSS hostility item scores and PANSS-Excited Component scores. They found that patients with hostility at baseline experienced reduced PANSS hostility item scores if they had received treatment with either HP-3070 dosage, beginning at week 2. Adjusting for hostility score of PANSS-Positive symptoms of schizophrenia and somnolence or akathisia symptoms, the researchers found that the HP-3070 7.6 mg/24 h dosage was more effective than placebo at weeks 2, 5, and 6 and that the lower dose was more effective than placebo at weeks 4 and 5. Patients with hostility symptoms at baseline experienced significant improvements in PANSS-Excited Component scores compared with placebo.

“In this post-hoc analysis, HP-3070 was superior to placebo in reducing schizophrenia-associated hostility, even after adjusting for covariates, suggesting that these effects are at least partially independent of general antipsychotic effects or effects on sedation or akathisia,” the researchers said. “These findings suggest HP-3070 may have a specific anti-hostility effect in patients with schizophrenia.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. This research was supported by Hisamitsu Pharmaceutical Co., Inc. Please see the original reference for a full list of authors’ disclosures.

Reference

Citrome L, Komaroff M, Starling B, Byreddy S, Terahara T, Hasabe M. Effect of the HP-3070 transdermal system on symptoms of hostility in adults with schizophrenia. Poster presented at: Psych Congress 2021, October 29-November 1, 2021; San Antonio, Texas. Poster 31.