New Hyperhidrosis Treatment Approval Expected in Mid-2024 Following FDA Delay

Sofpironium bromide, a new chemical entity for the treatment of primary axillary hyperhidrosis, is in the pipeline for United States Food and Drug Administration (FDA) review within the year.¹

Botanix Pharmaceuticals Limited has submitted a new drug application (NDA) for US regulatory approval for its new product, Sofdra gel 15%, and expects approval in mid-2024 and commercial launch later in the year.

Promising Results

The NDA is based on positive results from a phase 3 pivotal clinical program in which approximately 85% of patients experienced clinically meaningful improvement of their hyperhidrosis symptoms. More than 700 patients were enrolled in the study and approximately 300 participated in a 48-week safety study. No treatment-related serious adverse events were reported, according to Botanix, and mild to moderate adverse events were transient.²

Sofdra is a topical anticholinergic/antimuscarinic that blocks sweating at the gland. The agent is designed to be used once daily via an applicator to allow the patient to avoid drug contact with the hands, according to Botanix. The company believes Sofdra has promising potential as a best-in-class solution.

The Pathway to Approval

In Japan, the drug has been available since 2020 under the name Ecclock, which is a 5% formulation produced by Botanix partner Kaken Pharmaceutical. A 2-week observational study in Japanese patients using Ecclock found that after 1 week of treatment, approximately 50% of patients with a Hyperhidrosis Disease Severity Scale (HDSS) of 3 or 4 reported a reduced score of 1 or 2, a clinically significant improvement.³

The only topical anticholinergic currently used for hyperhidrosis treatment is glcopyrroniumtosylate (Qbrexza), which the FDA approved in 2018.⁴ Unpleasant adverse effects (including dry mouth, blurred vision, mydriasis, urinary hesitation, constipation, and dry eyes) often lead patients with hyperhidrosis to avoid or discontinue use of systemic oral anticholinergics. One study found systemic absorption of topical glcopyrroniumtosylate was significantly lower than absorption of oral glycopyrrolate, and patients using the topical treatment experienced fewer anticholinergic adverse events.⁵

Sofdra encountered a setback in September 2023 when an FDA letter identified a deficiency in the product’s Instructions for Use (IFU), which led Botanix in December to resubmit the NDA with revised IFU following a successful human factors validation study. This demonstrated that patients were able to understand the reworded IFU.

References

1. Botanix resubmission of NDA for Sofdra completed. Botanix Pharmaceuticals. Published December 21, 2023. Accessed January 15, 2024. https://botanixpharma.com/botanix-resubmission-of-nda-for-sofdra-completed/
2. Stocum L. Brickell Biotech provides update on phase 3 sofpironium bromide gel studies. Dermatology Times. July 8, 2021. Accessed January 12, 2024. https://www.dermatologytimes.com/view/brickell-biotech-update-phase-3-sofpironium-bromide-gel-studies.
3. Fujimoto T, Okatsu H, Miyama H. Two-week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis. J Dermatol. 2022;49(6):594-599. doi:10.1111/1346-8138.16384
4. FDA approves treatment for underarm sweating. Dermatology Times. March 14, 2023. Accessed January 12, 2024. https://www.dermatologytimes.com/view/fda-approves-treatment-underarm-sweating.
5. Pariser DM, Lain EL, Mamelok RD, Drew J, Mould DR. Limited systemic exposure with topical glycopyrronium tosylate in primary axillary hyperhidrosis. Clin Pharmacokinet. 2021;60(5):665-676. doi:10.1007/s40262-020-00975-y