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Factor Analysis Investigating the Efficacy of HP-3070 Transdermal System in Positive and Negative Syndrome Scale Five Adults With Schizophrenia
- Leslie Citrome, Mariacristina Castelli, Sandeep Byreddy, Masami Hasebe, Takaaki Terahara, Justin Faden, Marina Komaroff
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- Journal:
- CNS Spectrums / Volume 28 / Issue 2 / April 2023
- Published online by Cambridge University Press:
- 14 April 2023, pp. 243-244
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Introduction
HP-3070, a once-daily asenapine transdermal system, is FDA-approved for adults with schizophrenia. In a pivotal phase 3 randomized controlled study, patients with schizophrenia who were treated once daily with HP-3070 demonstrated significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores compared with placebo. The PANSS score’s five-factor structure can also assess treatment efficacy across different domains. This post-hoc analysis of the pivotal study evaluated the efficacy of HP-3070 by examining these domains.
MethodsIn the pivotal phase 3 study, adults with acute exacerbations of schizophrenia were randomized to 6 weeks of treatment with HP-3070 3.8mg/24h, 7.6mg/24h, or placebo. Factor analysis of PANSS scores was performed using five domains (negative symptoms, positive symptoms, disorganized thought, uncontrolled hostility/excitement, anxiety/depression). Mixed-model repeated-measures (MMRM) analysis included change from baseline in PANSS factor score as the repeated dependent variable, with country, treatment, visit, treatment by visit interaction, and baseline PANSS score as covariates.
ResultsThe analysis included 607 patients. Least-squares mean estimates (standard error) of the difference from placebo in change from baseline to Week 6 for each factor were as follows: negative symptoms, 3.8mg/24h, -0.9 (0.43), P=0.045, and 7.6mg/24h, -0.4 (0.43), P=0.41; positive symptoms, 3.8mg/24h, -2.3 (0.57), P<0.001, and 7.6mg/24h, -2.0 (0.57), P<0.001; disorganized thought, 3.8mg/24h, -1.5 (0.38), P<0.001, and 7.6mg/24h, -0.9 (0.38), P=0.03; uncontrolled hostility/excitement: 3.8mg/24h, -1.1 (0.30), P<0.001, and 7.6mg/24h -0.9 (0.30), P=0.002; anxiety/depression, 3.8mg/24h, -0.5 (0.31), P=0.14, and 7.6mg/24h, -0.6 (0.31), P=0.07.
ConclusionsHP-3070 demonstrated treatment effects on a PANSS five-factor model, with the results indicating impact on negative symptoms, positive symptoms, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression. These findings suggest that HP-3070 may address a broad range of symptoms in schizophrenia.
FundingNoven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical, Co.
Effect of the HP-3070 Transdermal System (Secuado ) on Symptoms of Hostility in Adults with Schizophrenia
- Leslie Citrome, Marina Komaroff, Brittney Starling, Sandeep Byreddy, Takaaki Terahara, Masami Hasabe
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- Journal:
- CNS Spectrums / Volume 27 / Issue 2 / April 2022
- Published online by Cambridge University Press:
- 28 April 2022, p. 241
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Background
Patients with schizophrenia may exhibit symptoms of hostility. HP-3070, a once-daily asenapine transdermal system, is the first antipsychotic patch approved by the FDA for use in adults with schizophrenia, and its efficacy in this indication has been demonstrated. This post hoc analysis of a phase 3 randomized study investigated the efficacy of HP-3070 in treating hostility in patients with schizophrenia.
MethodsIn the pivotal phase 3 study, adults with schizophrenia were randomized 1:1:1 to once-daily treatment with HP-3070 3.8 mg/24 h, 7.6 mg/24 h, or placebo for 6 weeks. Least-squares mean (LSM) changes in the PANSS hostility item score (P7) and PANSS-Excited Component (PANSS-EC), the sum of items P4 (Excitement), P7 (Hostility), G4 (Tension), G8 (Uncooperativeness), and G14 (Poor impulse control), from baseline to week 6 were assessed post hoc. Efficacy was analyzed with a mixed-effects model for repeated measures (MMRM) adjusted for PANSS-positive symptoms, items P1 (Delusions), P2 (Conceptual disorganization), P3 (Hallucinatory behavior), P5 (Grandiosity), P6 (Suspiciousness/persecution), and G9 (Unusual thought content) and presence of somnolence (including hypersomnia, hypersomnolence, or sedation) or akathisia.
ResultsAmong the 369 patients with a baseline PANSS hostility item score >1 and hostility scores collected at both baseline and week 6 (126 HP-3070 7.6 mg/24 h; 123 3.8 mg/24 h; 120 placebo), the week 6 LSM (95% CI) change from baseline in PANSS hostility item score was significantly better with HP-3070 than placebo for 7.6 mg/24 h (−0.4 [−0.6, −0.2]; P < .001) and 3.8 mg/24 h (−0.3 [−0.6, −0.1]; P < .01). Similar results were observed after adjusting for covariates (P < .01 for both doses). The week 6 PANSS-EC LSM change from baseline was also greater for HP-3070 7.6 mg/24 h (−1.1 [−1.9, −0.4]; n = 164; P < .01) and 3.8 mg/24 h (−1.3 [−2.0, −0.6]; n = 168; P < .001) compared with placebo (n = 165).
ConclusionsIn this post hoc analysis, HP-3070 was superior to placebo in reducing hostility in patients with schizophrenia, even after adjusting for covariates, suggesting that these effects are at least partially independent of general antipsychotic effects or of effects on sedation or akathisia. These findings suggest that HP-3070 may have a specific anti-hostility effect in patients with schizophrenia.
FundingNoven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical, Co.