Dr. August Wolff GmbH & Co. KG Arzneimittel, a German pharmaceutical company, announces the submission of an extension of the indication for its 1% glycopyrronium bromide (GPB) cream. The extension aims to include adolescents (aged 12 years and older) with severe primary axillary hyperhidrosis. Since its launch in June 2022, the 1% GPB cream has been approved in 23 EU countries for the treatment of severe axillary hyperhidrosis in adults (aged 18 and older).
About a Study with 1% GPB Cream in Adolescents between 12 and 17 Years of Age
The application is supported by a successfully conducted open-label, uncontrolled, multicentre Phase II study in adolescent patients. The primary objective of the study was to evaluate the safety, local tolerability, and efficacy of the 1% GPB cream.
Following 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 dosage regimen remained unchanged from that of the adults (in the first four weeks, the cream was applied two strokes per armpit daily), and in the following four weeks (weeks 5-8), the frequency of application could be adjusted to the symptoms (at least twice a week, with a maximum of 7 times a week).
Convincing Safety and Efficacy of the 1% GPB Cream
The cream was very well tolerated by the adolescents, with no local intolerances reported. The safety of the cream was also convincing: only two patients experienced adverse drug reactions, which were mild and reversible. Sweat production was significantly reduced in the first four weeks and continued to decrease during the flexible application phase (weeks 5-8). Parallel to the reduction in sweat production, the patients‘ quality of life improved significantly (statistically significant reduction in the Children’s Dermatology Life Quality Index (CDLQI) and the severity of hyperhidrosis assessed by the patient).
The results of this study demonstrate that the 1% GPB cream is a well-tolerated, safe, and effective medication for the treatment of severe primary axillary hyperhidrosis in adolescents (aged 12-17 years).
“The positive results of the Phase II study confirm that the cream is well tolerated and effective not only in adults but also in adolescents. We hope to help young patients manage this debilitating disease during their formative years. Our product is also anchored in the German guideline as a new topical therapy alongside antiperspirants,” says Dr. Erik Schulze zur Wiesche, Head of Research and Development at Dr. Wolff Group.
¹Abels C et al, Br J Dermatol 2021; 185(2):315-22
²Szeimies R-M et al, J Eur Acad Dermatol Venereol 2023; 37(4):823-30
Further Information on: www.axhidrox.com
