FDA Approves Sofpironium (Sofdra) as First and Only Chemical Entity for Primary Axillary Hyperhidrosis

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The US Food and Drug Administration (FDA) has approved Botanix Pharmaceutical's sofpironium (Sofdra) topical gel, 12.45% for adults and children ages 9 and older with primarily 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 3 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.²

"The approval of Sofdra is terrific news for the hyperhidrosis community, which has been frustrated by the lack of effective and convenient treatment options," said David Pariser, MD, in a news release.¹

Pariser is a founding board member of the International Hyperhidrosis Society and past President of the American Academy of Dermatology.

"The availability of a new treatment alternative that is topical, well-tolerated, effective and easy to use is truly exciting and would be welcomed amongst patients and physicians," Pariser said.

Botanix plans to launch an early patient experience program in the third quarter of 2024 to enable patients to receive early access to sofpironium, with a broader launch anticipated in the fourth quarter of the year.

"We are pleased to share this accomplishment with our dedicated Botanix team and dermatologist partners, patients who participated in the clinical studies and our shareholders who made this approval possible," said Botanix Chief Executive Officer Howie McKibbon, PharmD, MBA, in a news release.¹ "This is a transformative event for Botanix as we transition from a development stage to a revenue generating dermatology company."

References

1. FDA approval of Sofdra - the first new drug for primary axillary hyperhidrosis. News release. Botanix Pharmaceuticals. June 20, 2024. Accessed June 21, 2024. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299
2. Botanix resubmission of NDA for Sofdra completed. News release. Botanix Pharmaceuticals. December 21, 2023. Accessed June 21, 2024. https://botanixpharma.com/botanix-resubmission-of-nda-for-sofdra-completed/