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Psych Congress  

Efficacy and Safety of an Asenapine Transdermal System (HP-3070) for Treatment of Adults with Schizophrenia: A Phase 3 Randomized, Placebo-Controlled, Inpatient Study

Authors  

Leslie Citrome, MD, MPH – New York Medical College; David Walling, PhD – CNS Network, LLC; Courtney Zeni, PhD – Noven Pharmaceuticals, Inc.; Marina Komaroff, DrPH – Noven Pharmaceuticals, Inc.; Alexandra Park, BSc – Noven Pharmaceuticals, Inc.

Sponsor  
Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co.

Background: HP-3070, an asenapine transdermal patch for schizophrenia, offers favorable pharmacokinetics with minimal peak and trough fluctuations.

Methods: In this Phase 3, double-blind, inpatient study, adults with schizophrenia, Positive and Negative Syndrome Scale (PANSS) scores ≥80, and Clinical Global Impression-Severity of Illness Scale (CGI-S) scores ≥4 were randomized (1:1:1) to HP-3070 low-dose, HP-3070 high-dose (equivalent to sublingual asenapine 5mg and 10mg BID, respectively), or placebo. Primary endpoint was Week 6 PANSS score change from baseline (CFB) vs placebo; key secondary endpoint was Week 6 CGI-S score CFB vs placebo. Safety measures included treatment-emergent adverse events (TEAEs) and dermal assessments.

Results: 614 patients received study medication (204 high-dose, 204 low-dose, 206 placebo). Week 6 CFB was significantly better for treatment groups versus placebo, with least squares mean (LSM) (standard error [SE]; 95% CI) estimates of PANSS score as -4.8 (1.634; -8.06, -1.64; p=0.003) and -6.6 (1.630; -9.81, -3.40; p<0.001) for high- and low-dose groups, respectively. Similarly, CGI-S Week 6 LSM estimates were -0.4 (0.100; -0.55, -0.16; p<0.001) and -0.4 (0.099; -0.64, -0.25; p<0.001). HP-3070 safety profile was consistent with sublingual asenapine. Incidence of patch application site TEAEs was higher for HP-3070 (14.2% high-dose, 15.2% low-dose) vs placebo (4.4%), although discontinuations for application site reactions or skin disorders were ≤0.5% across groups.

Conclusions: In this study, HP-3070 was efficacious, safe, and well-tolerated in treating schizophrenia, meeting primary and key secondary endpoints for both doses. As the first transdermal antipsychotic patch in the US, HP-3070 will offer a novel treatment option for schizophrenia.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.

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