Anti-cholinergic gel demonstrates superior long-term tolerability and efficacy in axillary hyperhidrosis

Sofpironium gel proved effective and well tolerated in primary axillary hyperhidrosis in children and adults for a treatment period over a year.

The vast majority of patients suffering from hyperhidrosis report a profound negative impact on their social life, well-being, and emotional and mental health [1]. “Long-term treatment of primary axillary hyperhidrosis is often necessary given the chronic nature of the condition; therefore, chronic use has to be studied,” explained Dr Brandon M. Kirsch (Kirsch Dermatology, USA) [2]. Sofpironium is an analogue of the anti-cholinergic agent glycopyrrolate. Sofpironium is a retro-metabolic molecule that is rapidly metabolised into less active moieties following absorption after topical application. “Glycopyrrolate has more systemic side effects, in contrast to sofpironium,” Dr Kirsch explained.

The long-term safety, tolerability, and efficacy of sofpironium gel was evaluated in an open-label phase 3 trial (NCT03627468) including adult and paediatric subjects (n=300) with primary axillary hyperhidrosis. All participants were randomised to receive either sofpironium bromide gel 5% or 15%. Patients enrolled were naïve to the treatment; 190 patients completed the 52 weeks’ study duration.

The safety results of the gel were consistent with a prior phase 2b dose-finding study. Most adverse events were mild or moderate and transient. Side effects were typical anti-cholinergic adverse events, most often dry mouth (in 7.8% of patients using the 5% gel and 16.8% using the 15% gel), and blurred vision (in 4.9% of patients using the 5% gel and 18.8% using the 15% gel).

The incidence of treatment-related adverse events decreased over time: after 12 weeks, there were no new side effects. “This finding suggests that patients have to get used to the medication, and they did in the trial,” Dr Kirsch explained. In line with these results, the incidence of discontinuations due to treatment-related adverse events decreased over time as remaining subjects acclimated to treatment. There were no treatment-related serious adverse events.

In terms of efficacy (assessed in the Hyperhidrosis Disease Severity Measure-Axillary) the gel demonstrated clinically meaningful reduction in sweat severity from week 2 until the end of the study.

1. Doolittle J, et al. Arch Dermatol Res 2016;308(10):743-9.
2. Schmid S, et al. A Multicenter, Randomized, Open-Label, Phase 3 long-term safety study of topically applied sofpironium bromide gel, 5% and 15%, in subjects with axillary hyperhidrosis. S033, AAD VMX 2021, 23-25 April.

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Posted on 7 June 20217 June 2021