Tags

Type your tag names separated by a space and hit enter

146 Efficacy and Safety of the Asenapine Transdermal Patch, HP-3070, for Schizophrenia: A Phase 3, Randomized, Placebo-Controlled, Inpatient Study.
CNS Spectr. 2020 Apr; 25(2):293.CS

Abstract

BACKGROUND

Asenapine is a 2nd-generation antipsychotic currently marketed as a sublingual (SL) tablet in the US for the treatment of schizophrenia. HP-3070, asenapine transdermal system, is a patch for treatment of schizophrenia in adults. Low- and high- HP-3070 doses deliver asenapine concentrations that are similar to SL asenapine 5 mg BID and 10 mg BID, respectively, but with fewer peak and trough fluctuations.

METHODS

In this Phase 3, randomized, double-blind, placebo (PBO)-controlled, 6-week inpatient study, adults with schizophrenia having baseline Positive and Negative Syndrome Scale (PANSS) total score ≥80 and Clinical Global Impression-Severity of Illness Scale (CGI-S) score ≥4 were randomized 1:1:1 to HP 3070 high-dose, HP-3070 low-dose, or PBO.The primary efficacy objective was Week 6 PANSS score change from baseline (CFB) vs PBO.The key secondary objective was Week 6 CGI-S CFB vs PBO. Safety assessments included treatment-emergent adverse events (TEAEs), laboratory results, vital signs, dermal safety, and extrapyramidal symptoms (EPS) assessments.

RESULTS

A total of 616 patients were randomized, with 486 patients completing the study. Discontinuation rates were 23.3%, 18.6%, and 21.4% for HP-3070 high-dose, HP-3070 low-dose, and PBO, respectively; withdrawal of consent and AEs were the most common reasons for discontinuation. Demographics and baseline characteristics were well-balanced among treatment groups.For PANSS total score, least squares mean (LSM) (standard error [SE]) estimates of the treatment comparison (HP-3070 vs PBO) for CFB at Week 6 were -4.8 (1.634; 95% CI: -8.06, -1.64; p=0.003) and -6.6 (1.630; 95% CI: 9.81, 3.40; p<0.001) for HP-3070 high- and low-dose, respectively. For CGI-S CFB at Week 6, LSM (SE) for the treatment comparison were 0.4 (0.100; 95% CI: 0.55, 0.16; p<0.001) for HP 3070 high-dose and 0.4 (0.099; 95% CI: 0.64, 0.25; p<0.001) for low-dose.No deaths or serious TEAEs related to study treatment occurred. The HP-3070 safety profile was consistent with SL asenapine. Incidence of TEAEs at the patch application site was higher for HP-3070 (14.2% high-dose, 15.2% low-dose) than for PBO (4.4%); most of these events were mild or moderate in severity. PBO patients had higher rates of psychiatric disorders (24.3% vs 15.7% and 17.6% for HP-3070 high- and low-dose, respectively), with insomnia and anxiety as most common. Study treatment discontinuations due to application site reactions or skin disorders were low (≤0.5%) across treatment groups. There was no marked mean CFB for vital signs or electrocardiogram parameters, nor treatment differences observed on EPS assessments.

CONCLUSIONS

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

FUNDING ACKNOWLEDGEMENTS

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

Authors+Show Affiliations

Clinical Professor, Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA.Chief Executive Officer, CNS Network, LLC, Garden Grove, CA, USA.Director of Medical Affairs, Product Development, Noven Pharmaceuticals, Inc., Jersey City, NJ, USA.Director of Biostatistics, Product Development, Noven Pharmaceuticals, Inc., Jersey City, NJ, USA.Executive Director, Regulatory Affairs and Pharmacovigilance, Noven Pharmaceuticals, Inc., Jersey City, NJ, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32331019

Citation

Citrome, Leslie, et al. "146 Efficacy and Safety of the Asenapine Transdermal Patch, HP-3070, for Schizophrenia: a Phase 3, Randomized, Placebo-Controlled, Inpatient Study." CNS Spectrums, vol. 25, no. 2, 2020, p. 293.
Citrome L, Walling D, Zeni C, et al. 146 Efficacy and Safety of the Asenapine Transdermal Patch, HP-3070, for Schizophrenia: A Phase 3, Randomized, Placebo-Controlled, Inpatient Study. CNS Spectr. 2020;25(2):293.
Citrome, L., Walling, D., Zeni, C., Komaroff, M., & Park, A. (2020). 146 Efficacy and Safety of the Asenapine Transdermal Patch, HP-3070, for Schizophrenia: A Phase 3, Randomized, Placebo-Controlled, Inpatient Study. CNS Spectrums, 25(2), 293. https://doi.org/10.1017/S1092852920000620
Citrome L, et al. 146 Efficacy and Safety of the Asenapine Transdermal Patch, HP-3070, for Schizophrenia: a Phase 3, Randomized, Placebo-Controlled, Inpatient Study. CNS Spectr. 2020;25(2):293. PubMed PMID: 32331019.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 146 Efficacy and Safety of the Asenapine Transdermal Patch, HP-3070, for Schizophrenia: A Phase 3, Randomized, Placebo-Controlled, Inpatient Study. AU - Citrome,Leslie, AU - Walling,David, AU - Zeni,Courtney, AU - Komaroff,Marina, AU - Park,Alexandra, PY - 2020/4/26/entrez PY - 2020/4/26/pubmed PY - 2020/4/26/medline SP - 293 EP - 293 JF - CNS spectrums JO - CNS Spectr VL - 25 IS - 2 N2 - BACKGROUND: Asenapine is a 2nd-generation antipsychotic currently marketed as a sublingual (SL) tablet in the US for the treatment of schizophrenia. HP-3070, asenapine transdermal system, is a patch for treatment of schizophrenia in adults. Low- and high- HP-3070 doses deliver asenapine concentrations that are similar to SL asenapine 5 mg BID and 10 mg BID, respectively, but with fewer peak and trough fluctuations. METHODS: In this Phase 3, randomized, double-blind, placebo (PBO)-controlled, 6-week inpatient study, adults with schizophrenia having baseline Positive and Negative Syndrome Scale (PANSS) total score ≥80 and Clinical Global Impression-Severity of Illness Scale (CGI-S) score ≥4 were randomized 1:1:1 to HP 3070 high-dose, HP-3070 low-dose, or PBO.The primary efficacy objective was Week 6 PANSS score change from baseline (CFB) vs PBO.The key secondary objective was Week 6 CGI-S CFB vs PBO. Safety assessments included treatment-emergent adverse events (TEAEs), laboratory results, vital signs, dermal safety, and extrapyramidal symptoms (EPS) assessments. RESULTS: A total of 616 patients were randomized, with 486 patients completing the study. Discontinuation rates were 23.3%, 18.6%, and 21.4% for HP-3070 high-dose, HP-3070 low-dose, and PBO, respectively; withdrawal of consent and AEs were the most common reasons for discontinuation. Demographics and baseline characteristics were well-balanced among treatment groups.For PANSS total score, least squares mean (LSM) (standard error [SE]) estimates of the treatment comparison (HP-3070 vs PBO) for CFB at Week 6 were -4.8 (1.634; 95% CI: -8.06, -1.64; p=0.003) and -6.6 (1.630; 95% CI: 9.81, 3.40; p<0.001) for HP-3070 high- and low-dose, respectively. For CGI-S CFB at Week 6, LSM (SE) for the treatment comparison were 0.4 (0.100; 95% CI: 0.55, 0.16; p<0.001) for HP 3070 high-dose and 0.4 (0.099; 95% CI: 0.64, 0.25; p<0.001) for low-dose.No deaths or serious TEAEs related to study treatment occurred. The HP-3070 safety profile was consistent with SL asenapine. Incidence of TEAEs at the patch application site was higher for HP-3070 (14.2% high-dose, 15.2% low-dose) than for PBO (4.4%); most of these events were mild or moderate in severity. PBO patients had higher rates of psychiatric disorders (24.3% vs 15.7% and 17.6% for HP-3070 high- and low-dose, respectively), with insomnia and anxiety as most common. Study treatment discontinuations due to application site reactions or skin disorders were low (≤0.5%) across treatment groups. There was no marked mean CFB for vital signs or electrocardiogram parameters, nor treatment differences observed on EPS assessments. CONCLUSIONS: In this study, HP-3070 was efficacious, safe, and well-tolerated for treating schizophrenia in adults; both doses met primary and key secondary endpoints. As the first transdermal antipsychotic patch in the US, HP-3070 will provide patients a novel treatment option. FUNDING ACKNOWLEDGEMENTS: Funded by Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co. SN - 1092-8529 UR - https://www.unboundmedicine.com/medline/citation/32331019/146_Efficacy_and_Safety_of_the_Asenapine_Transdermal_Patch,_HP-3070,_for_Schizophrenia:_A_Phase_3,_Randomized,_Placebo-Controlled,_Inpatient_Study L2 - https://www.cambridge.org/core/product/identifier/S1092852920000620/type/journal_article DB - PRIME DP - Unbound Medicine ER -
Try the Free App:
Prime PubMed app for iOS iPhone iPad
Prime PubMed app for Android
Prime PubMed is provided
free to individuals by:
Unbound Medicine.