麻豆传媒

The antipsychotic "patch" effectively reduced hostility among patients with schizophrenia, a researcher reported.

In a post-hoc analysis of a phase III trial, once-daily asenapine transdermal system (Secuado) -- the first transdermal patch FDA-approved for schizophrenia -- was superior to placebo in reducing symptoms of hostility related to schizophrenia, reported Leslie Citrome, MD, MPH, of New York Medical College in Valhalla.

Specifically, patients on the 7.6 mg/24-hour patch saw a 0.4-point (-0.6 to -0.2, P<0.001) drop from baseline in hostility item score measured by the Positive and Negative Syndrome Scale (PANSS), Citrome and colleagues reported in a poster at the Psych Congress 2021, held virtually and in San Antonio, Texas.

With this benefit at week 2 of treatment, patients saw more than a two times higher odds of hostility improvement by week 6 of treatment with the 7.6 mg-patch (OR 2.19, 95% CI 1.32-3.63, P=0.0024).

Those on the lower-dose patch (3.8 mg/24h) also saw a benefit, marked by a -0.3 point (-0.6 to -0.1, P<0.01) drop from baseline in hostility score. These patients also saw a similar significant benefit by week 2 of treatment, and had nearly a two times higher odds of improving hostility (OR 1.91, 95% CI 1.15-3.18, P=0.01).

Even 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 -- delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution, unusual thought content -- and the presence of somnolence including hypersomnia, hypersomnolence, sedation, and akathisia.

"This suggests that these effects are at least partially independent of general antipsychotic effects or of effects on sedation or akathisia," Citrome pointed out. "These findings indicate that transdermal asenapine may have a specific anti-hostility effect in patients with schizophrenia."

Both patch doses also demonstrated significant improvements in the change from baseline in PANSS-Excited Component score compared with placebo.

The patch was green lit by the FDA in 2019 and is currently available in three doses: 3.8 mg/24h, 5.7 mg/24h, and 7.6 mg/24h. It carries a boxed warning label on increased mortality in elderly patients with dementia-related psychosis.

This post-hoc analysis included a subset of patients from the , led by Citrome, of the asenapine transdermal system. All patients in this trial were adults experiencing an acute exacerbation of schizophrenia with a Clinical Global Impression-Severity of Illness scale score of at least 4 and a PANSS total score of at least 80.

All participants also had a minimum score of 4 at the time of screening in the pre-defined PANSS positive subscale items, and a minimum score of 2 at baseline.

The mean age of all patients was 42.3, nearly 54% were male, and more than 75% were white.

This analysis was restricted to patients experiencing some degree of schizophrenia-related hostility at baseline, marked by a PANSS Hostility Item Score of at least 1. A total of 151 patients were assigned to received the 7.6 mg/24h-patch, while 149 patients wore the 3.8 mg/24h-patch, and 147 patients wore a placebo patch.

The most common side effects reported in the trial were restlessness, difficulty moving, muscle stiffness, tremor, skin irritation where the patch was placed, and weight gain.

"As the first transdermal antipsychotic approved by the FDA, transdermal asenapine provides a novel formulation that may address symptoms in schizophrenia patients that are of considerable clinical significance," Citrome concluded.

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