PRIMARY axillary hyperhidrosis is a condition affecting 4.8% of the U.S. population, characterised by excessive sweating in the underarms. This condition significantly impacts patients’ quality of life, often necessitating frequent showers and clothing changes. Treatment options include prescription antiperspirants, oral and topical anticholinergics, botulinum toxin injections, and surgical interventions. However, many patients are dissatisfied with current therapies due to their invasiveness, side effects, or limited efficacy.
Sofpironium gel, a newly approved topical treatment, offers a promising alternative. It belongs to a class of retrometabolic drugs designed to enhance local effectiveness while reducing systemic side effects. Sofpironium selectively inhibits M3 muscarinic receptors in sweat glands, reducing perspiration. Unlike other anticholinergics, it undergoes rapid metabolism into inactive compounds, minimising adverse effects such as dry mouth and blurred vision.
Phase 3 clinical trials in the United States demonstrated significant improvements in hyperhidrosis symptoms using sofpironium gel (12.45%) compared to a placebo. Patients reported symptom relief as early as one week after starting treatment, with continued benefits over the six-week trial. The gel must be applied daily to maintain its effect, as its action ceases once treatment stops.
The study also highlighted the psychological burden of hyperhidrosis, linking the condition to increased anxiety, depression, and impaired quality of life. Axillary hyperhidrosis was found to be particularly distressing, often leading to social embarrassment and reduced self-esteem.
Compared to topical glycopyrronium, another anticholinergic treatment, sofpironium gel exhibited a more favourable safety profile. Reported side effects were lower for dry mouth (14.2% vs. 24.2%), erythema (6.2% vs. 17.0%), and pruritus (4.5% vs. 8.1%). Long-term studies over 48 weeks confirmed its safety and tolerability, with most adverse events being mild and transient.
Although current trials were limited to short-term use, a separate one-year study demonstrated sustained efficacy. Sofpironium gel represents a breakthrough in hyperhidrosis management, offering an effective, non-invasive solution with fewer side effects than existing treatments.
Katie Wright, EMJ
Reference
Pariser D et al. Sofpironium topical gel, 12.45%, for the treatment of axillary hyperhidrosis: pooled efficacy and safety results from 2 phase 3 randomized, controlled, double-blind studies. J Am Acad Dermatol. 2025;DOI:10.1016/j.jaad.2025.02.086
