Long-Term Efficacy and Safety of 1% Glycopyrronium Bromide Cream in Patients With Severe Primary Axillary Hyperhidrosis

TAKE-HOME MESSAGE

• In this long-term, open-label, phase IIIb study, 518 patients with primary axillary hyperhidrosis (PAHH) were treated with topical 1% glycopyrronium bromide (GPB) cream once daily for 4 weeks and then a minimum of twice weekly for the remaining 72 weeks. A significant reduction in sweat production was noted at week 12 compared with the baseline measures. The quality-of-life measures were significantly improved throughout the study compared with the baseline measures. Overall, GPB cream was well-tolerated, with dry mouth being the most commonly reported adverse event.
• Topical 1% GPB cream has the potential to be a more cost-effective alternative to glycopyrronium tosylate wipes in the US for the treatment of patients with PAHH.

–  Ruth McTighe, MD

Abstract

BACKGROUND

Primary axillary hyperhidrosis (PAHH) strongly affects the patient's quality of life. To date, topical treatment options are limited. One percent glycopyrronium bromide (GPB) showed promising efficacy and safety in a pivotal 4-week Phase 3a study.

OBJECTIVES

To assess efficacy and safety of topical 1% GPB cream in patients with severe PAHH in a long-term study of 72 weeks versus baseline.

METHODS

This was a long-term, open-label, Phase 3b trial for 72 weeks including 518 patients with severe PAHH. Patients were treated with 1% GPB cream once daily for 4 weeks, followed by a flexible dosing scheme (min. twice per week, max. once daily). Primary endpoint was the absolute change in sweat production from baseline to week 12. Further study endpoints included assessment of the severity of PAHH and the impact on quality of life.

RESULTS

Total median sweat production decreased by 119.30 mg (-65.6%, both median) until week 12. Absolute change in sweat production from baseline to week 12 in logarithmic values was statistically significant (p < 0.0001). Patients' quality of life was improved at all study time points compared to baseline, as assessed by Hyperhidrosis Quality of Life Index and Dermatology Life Quality Index (p < 0.0001). Treatment was safe and locally well-tolerated with only few mild to moderate adverse drug reactions (ADRs). Dry mouth and application site erythema were the most common reported ADRs.

CONCLUSIONS

Treatment with 1% GPB cream over 72 weeks significantly reduces sweat production and improves quality of life in patients with severe PAHH. One percent GPB cream is well-tolerated and provides an effective treatment option for long-term use in patients with severe PAHH.

Journal of the European Academy of Dermatology and Venereology: JEADV

Long-term efficacy and safety of 1% glycopyrronium bromide cream in patients with severe primary axillary hyperhidrosis: Results from a Phase 3b trial

J Eur Acad Dermatol Venereol 2023 Jan 06;[EPub Ahead of Print], RM Szeimies, C Abels, A Kilic, H Reich, B Berger, E Schulze Zur Wiesche, K Schramm, L Litzka, S Heimstaedt-Muskett, C Masur 

Sent from my iPhone

Benjamin Hidalgo-Matlock
Skin Care Physicians of Costa Rica

Clinica Victoria en San Pedro: 4000-1054
Momentum Escazu: 2101-9574

Please excuse the shortness of this message, as it has been sent from
a mobile device.