New anticholinergic preparation is effective and tolerable in hyperhidrosis

Topically applied sofpironium bromide gel proved to be effective and well tolerated in the phase 3 Cardigan I and Cardigan II trials for patients with primary axillary hyperhidrosis. Both subjective and objective parameters were improved with only mild anticholinergic side effects due to its rapid metabolism.

Of patients suffering from hyperhidrosis, 75% report a profoundly negative impact on their social life, well-being, and emotional and mental health [1]. Long-term treatment is often necessary given the chronic nature of primary axillary hyperhidrosis. Sofpironium is an analogue of the anticholinergic agent glycopyrrolate. In contrast to the latter, sofpironium is a retro-metabolic molecule, which is designed to undergo rapid metabolism into less active moieties following absorption after topical application. Due to this short systemic half-life, better tolerability can be expected.

The identically designed Cardigan I (NCT03836287) and Cardigan II (NCT03948646) trials evaluated safety, local tolerability, and efficacy regarding sweat production, patient-reported outcomes, and quality-of-life self-assessment of the 15% gel [2]. In each study, 350 axillary hyperhidrosis patients aged 9 years or older were randomised to receive the gel or a vehicle cream for 6 weeks with an ensuing 2-week follow-up.

Overall, 89% of participants completed the 6 weeks of treatment. In both studies, the gel led to statistically significant reductions in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score of ≥2 points: 49.3% in the Cardigan I trial (compared with 29.4% in the vehicle group; P<0.001) and 63.9% of participants in the Cardigan II study (compared with 47% in the vehicle group; P=0.003) achieved this endpoint. Moreover, participants in the treatment group had a higher reduction of gravimetric sweat production (GSP) from baseline compared with the vehicle gel.

The gel was overall well tolerated. “Most adverse events were mild or moderate in severity and what we would expect from an anticholinergic such as a dry mouth, blurred vision, and application site pain,” Prof. David Pariser (Eastern Virginia Medical School, VA, USA) said. Application site pain was seen most frequently. Reassuringly, fewer anticholinergic effects and treatment discontinuations than expected occurred despite the relatively high concentration of 15%. Moreover, treatment-emergent adverse events (both systemic and local) decreased over time because, as Prof. Pariser put it, “patients got used to the treatment.”

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   1. Doolittle J, et al. Arch Dermatol Res. 2016;308(10):743–749.
   2. Pariser D, et al. Topically applied sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis: results from the Cardigan I and Cardigan II phase 3 multicenter, randomized, placebo-controlled trials. S026, AAD 2022 Annual Meeting, 25–29 March, Boston, MA, USA.

 

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Posted on 17 May, 202223 May, 2022