TOPLINE

Post-marketing surveillance of sofpironium gel, 12.45%, for primary axillary hyperhidrosis (PAH) found reported adverse events (AEs) consistent with the drug's known safety profile, with no new safety signals.

METHODOLOGY

• Researchers conducted a post-marketing safety surveillance analysis of sofpironium gel, 12.45%, a novel topical treatment for PAH in patients aged 9 years and older.
• A total of 20,667 sofpironium prescriptions were filled between June 18, 2024, and January 31, 2026.
• The researchers identified spontaneous AEs from the Botanix Global Safety Database and Periodic Adverse Drug Experience Reports and compared them with AEs from phase 3 trials involving 353 patients.
• Overall, 61.8% of patients received product beyond 42 days, the original phase 3 treatment duration.

TAKEAWAY

• Overall, 194 case reports involving 431 spontaneous AEs were identified; of these, 249 were drug-related.
• The most common drug-related AEs in the post-marketing period were blurred vision (0.32%), dry mouth (0.22%), application site pain (0.14%), and mydriasis (0.12%). No new AEs were identified.
• Drug-related anticholinergic AEs associated with muscarinic 3 receptor inhibition, including dry mouth, blurred vision, mydriasis, and urinary retention, were reported 25-64 times less frequently in the post-marketing period than in phase 3 trials. Application site treatment-related AEs occurred approximately 25-125 times less frequently in the post-marketing period compared with phase 3 studies.
• Of all, 16 serious drug-related AE reports encompassing 29 events occurred in the post-marketing period, including urinary retention (n = 15), blurred vision (n = 4), dry mouth (n = 3), mydriasis (n = 3), headache (n = 2), and application site pain (n = 2), which affected 0.08% of the post-marketing population.

IN PRACTICE

"Post-marketing AE types were generally consistent with sofpironium's known safety profile, reaffirming sofpironium's safety in the real-world setting and supporting a favorable benefit-risk profile in a broader, more diverse population," the authors wrote.

SOURCE

The study was led by Lawrence J. Green, MD, The George Washington University School of Medicine and Health Sciences, Washington, DC. It was published online on August 31 in the Journal of the American Academy of Dermatology.

LIMITATIONS

Limitations include potential bias, reliance on voluntary spontaneous reporting, underreporting and/or incomplete reports, and the inability to accurately gauge the number of patients using the medication.

DISCLOSURES

The analysis was supported by Botanix Pharmaceuticals. Green and other authors reported being study investigators and received research grants and fees. Two authors reported being employees of Botanix.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.