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Getting the latest healthcare news for you
Getting the latest healthcare news for you
A post-marketing analysis of sofpironium gel 12.45% — used to treat primary axillary hyperhidrosis — found no new safety signals across more than 20,000 prescriptions. Adverse events like dry mouth and blurred vision occurred far less frequently in real-world use than in clinical trials. The findings reinforce the drug's favorable benefit-risk profile in a broader, more diverse patient population.
A new post-marketing surveillance study confirms that sofpironium gel 12.45% is holding up well in the real world. Approved for primary axillary hyperhidrosis (PAH) — a condition causing excessive underarm sweating — in patients aged 9 and older, the gel was analyzed across more than 20,000 prescriptions filled between June 2024 and January 2026. Researchers found no new adverse events (AEs) beyond what was already known from clinical trials.
In fact, the real-world safety picture looks even better than trial data suggested. Anticholinergic side effects like dry mouth, blurred vision, and urinary retention occurred 25 to 64 times less frequently than in phase 3 studies, and application site reactions were 25 to 125 times less common.
By the Numbers:
Why it matters: For dermatologists and patients managing PAH, these findings offer reassurance that sofpironium gel remains safe and well-tolerated beyond the controlled trial setting — supporting its long-term use in everyday clinical practice.
