FDA approves sofpironium (Sofdra) as first and only chemical entity for primary axillary hyperhidrosis

It is now the first and only chemical entity approved for this indication.

Approval for sofpironium, a topical anticholinergic/antimuscarinic, is based on positive phase III clinical trial results, where approximately 85% of patients showed significant improvement in hyperhidrosis symptoms. The study included over 700 patients, with around 300 participating in a 48-week safety study. No serious adverse events related to the treatment were reported, and mild to moderate adverse events were temporary.

Sofpironium is intended for once-daily use with an applicator to avoid hand contact. It has been available in Japan since 2020 as Ecclock, a 5% formulation by Botanix's partner Kaken Pharmaceutical.

Prior to the approval, the only FDA-approved topical anticholinergic for hyperhidrosis was glycopyrronium tosylate (Qbrexza), approved in 2018. Patients often avoid systemic oral anticholinergics due to unpleasant side effects, which are less frequent with the topical form.

In December 2023, Botanix announced it had resubmitted a New Drug Application (NDA) for the treatment for sofpironium following a setback in September 2023 when the FDA identified an issue with its Instructions for Use (IFU). The revised IFU and NDA were submitted after a successful human factors validation study confirmed patient comprehension of the new instructions.

Hyperhidrosis is a debilitating, life-altering medical condition where a person sweats beyond what is physiologically required for thermoregulation of the body. More than 15 million people, or 4.8% of the population of the United States, and 12.76% of the population in Japan, are believed to suffer from hyperhidrosis. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States.