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: AXHIDROX®: Welcome to the Professionals Portal

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

Sweating. A vital process, but when people feel they sweat too much, it becomes a burden. Most of all for those who suffer from so-called primary hyperhidrosis – a condition that is characterised by excessively sweating for no apparent reason. The heavy sweat production often significantly affects the emotional and mental health of those affected.

It is assumed that around 5 percent[1] of the German population suffer from this chronic disease. However, the number of unreported cases is likely to be much higher, as many of those affected suffer silently and do not talk about their condition – neither to confidants nor to a doctor. It often takes several years before people affected reach out for help. Dr. Wolff, a pharmaceutical company based in Bielefeld, Germany, wants to lower exactly this inhibition threshold – with a new online service:

Disease awareness website aims to bring illness out of niche

To raise awareness of hyperhidrosis among the general public Dr. Wolff launched a digital information platform succinctly named nervtdichdeinschwitzen.de (= does your sweating annoy you). The main concern of the site is to provide detailed and interesting information about this comparatively unknown illness.

The initiative pursues the self-declared goal of making a broad public aware of the clinical picture and to simplify the communication between doctor and patient. The site encourages users to consult a trusted physician and discuss their symptoms. Site users can do an initial symptom check and get a first estimate on whether their sweating could be pathological. Furthermore, they may search online for a physician via our online service page. NervtDichDeinSchwitzen.de offers various offline and online options to search for a physician and to lower the inhibition threshold to get in contact. 

Plea: “Go see a doctor you trust and get help”.

“We want knowledge about the illness to increase, for hyperhidrosis to become a topic of conversation, and for those affected to lose their fear and seek help,” explains Eduard R. Dörrenberg, managing partner of the pharmaceutical manufacturer Dr. Wolff. Because the good news is: pathological sweating is usually treatable, the psychological strain can be reduced and the quality of life improved. However, people affected need to see a physician they trust in. Many people do not know that sweating may in some cases be pathological – after all, to a certain extent it is a normal and vital bodily function. PD Dr. Christoph Schick, founder of the German Hyperhidrosis Center in Munich says: “If you are affected by hyperhidrosis, I strongly recommend: Do something about it! The sooner you do something, the longer you well benefit from the treatment effect.”

About hyperhidrosis

Approximately 5 % of people worldwide suffer from permanent excessive sweating without an identifiable cause, so-called “primary hyperhidrosis”. This chronic disease is a great burden for patients and severely limits their quality of life. Primary hyperhidrosis ranges in severity from mild wetness to heavy dripping and can lead to a significant impact on quality of life. This may significantly affect work, social relationships, physical and leisure activities, as well as emotional and mental health. Patients with primary axillary hyperhidrosis suffer from excessive sweat production in the armpits beyond the amount required to regulate normal body temperature.

About Dr. Wolff

Dr. Wolff – since 1905, the name has stood for research that solves people’s skin-, hair-, and dental problems with innovative active ingredients. We focus our effort on scientifically proven benefits of the products. Since the company was founded, Dr. Wolff has maintained close cooperation with renowned scientists. From the first branded product, Hämatopan, to today’s internationally available products, in-house research provides the basis for innovative active ingredients and product developments. The company is managed by the fourth generation of the family and is growing with 780 employees worldwide. Dr. Wolff operates in 62 countries. For more information, please go to: Dr. Wolff Group

Press Contact Dr. Wolff-Group

Marcel Klöpping          Phone: +49 (0) 521 8808-243

E-mail: pr@drwolffgroup.com

[1] Doolittle J, et al., Arch Dermatol Res 2016; 308(10): 743-749.