The Bielefeld-based pharmaceutical company Dr. August Wolff GmbH & Co. KG Arzneimittel has extended its clinical study programme with a 1% glycopyrronium bromide (GPB) cream for the treatment of severe primary axillary hyperhidrosis with a study in 12- to 17-year-olds. The convincing data were presented at the Congress of the European Academy of Dermatology and Venereology (EADV).
Primary axillary hyperhidrosis
Excessive, uncontrollable sweating under the armpits, known as severe primary axillary hyperhidrosis, often begins during puberty and significantly impairs the quality of life of patients during this particular phase of development. There are currently no approved topical drug therapies available in Germany.
Study with 1% GPB cream in adolescents between 12 and 17 years of age
After the positive results from the double-blind, placebo-controlled 4-week multicentre study (Phase 3a)1 and the 72-week open-label multicentre study (Phase 3b)2 in adults, the 1% GPB cream was investigated in 42 adolescents aged 12 to 17 years. For this purpose, the dose and dosing regimen were left unchanged from those used in adults (in the first four weeks, the cream was applied daily (2 pumps per armpit); in the following four weeks (weeks 5-8), the frequency of application could be adjusted according to the symptoms (at least twice a week, no more than seven times a week)).
Safety and efficacy of the 1% GPB cream are convincing
The cream was very well tolerated by the adolescents. There were no local intolerances. The safety of the cream was also convincing: only two patients showed adverse drug reactions, which were mild and reversible. Sweat production was significantly reduced in the first four weeks and continued to decrease in the flexible application phase (weeks 5-8). Along with the reduction in sweat volume, the patients’ quality of life improved significantly (statistically significant reduction in the Children Dermatology Life Quality Index (CDLQI) and in the patient-rated severity of hyperhidrosis).
The results of this study show that 1% GPB cream is a well-tolerated, safe and effective treatment for severe primary axillary hyperhidrosis in adolescents (12-17 years of age). The results were presented to the medical community at the EADV conference in Amsterdam from 25-28 September 2024.
The 1% GPB cream has been available in Germany since August 2022 under the name Axhidrox® as a prescription-only and reimbursable medication for patients aged 18 and over. An extension of the approval to adolescents from the age of twelve is planned.
1 Abels C et al, Br J Dermatol 2021; 185(2):315–22
2 Szeimies R-M et al, J Eur Acad Dermatol Venereol 2023; 37(4):823–30
