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FDA Approves Botanix Pharmaceuticals’ Sofdra for the Treatment of Primary Axillary Hyperhidrosis


Approval of Sofdra marks the first chemical entity to be approved by the FDA to treat primary axillary hyperhidrosis.

Hyperhidrosis - word from wooden blocks with letters, excessive sweating hyperhidrosis concept, top view on grey background. Image Credit: Adobe Stock Images/Siam

Image Credit: Adobe Stock Images/Siam

The FDA has approved Botanix’ Sofdra gel, 12.45%, for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in patients over 9 years of age. According to the company, this approval marks the first time that a chemical treatment has been approved by the government agency for primary axillary hyperhidrosis. The regulatory action was based on results from the Phase III CARDIGAN studies.1

“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 Howie McKibbon, PharmD, MBA, CEO, Botanix Pharmaceuticals, in a press release. “This is a transformative event for Botanix as we transition from a development stage to a revenue generating dermatology company.”

The CARDIGAN clinical trials included 701 patients and demonstrated noteworthy improvements in sweat reduction and disease severity, according to the investigators. Additionally, Botanix reported that all primary and secondary endpoints of the study were met, with the improvement being measured by baseline in Gravimetric Sweat Production and the Hyperhidrosis Disease Severity Measure-Axillary, 7-item score.

Botanix warns against the use of Sofdra if a patient has medical conditions that can be accelerated by taking an anticholinergic medicine including glaucoma, severe ulcerative colitis (UC), and serious bowel problems associated with severe UC, myasthenia gravis, and Sjogren’s syndrome. Serious adverse effects (AEs) include blurred vision and new or worsened urinary retention. More common AEs of Sofdra include dry mouth; blurred vision; pain, redness, swelling, itching, and irritation in the underarm area; dilation of the pupils; and issues with urination. When applying Sofdra, patients are urged to avoid the heat, as the treatment is highly flammable.1

According to an analysis from Future Market Insights (FMI) conducted last year, the global treatment market for axillary hyperhidrosis was valued at approximately $1.6 billion at the time of the study. Further, it’s expected to reach around $3.3 billion by 2033 at a compound annual growth rate (CAGR) of 6.7%. The company attributes this to the increasing use of medicated wipes and gels in the treatment of hyperhidrosis, which it attributed to convenience, efficacy, and safety, effectively boosting the market in the coming years. Between 2017-2022, the axillary hyperhidrosis treatment market grew at a CAGR of 7.2%.

Further, FMI credits the advancement of therapies such as iontophoresis and antiperspirants as a reason for axillary hyperhidrosis being treated more successfully in recent years. Reportedly, treatments such as miraDry, Botox injections, and lasers have been implemented as options for the treatment of axillary hyperhidrosis, which in turn has led to a higher use of these products in therapies currently on the market.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, hyperhidrosis expert, founding board member, International Hyperhidrosis Society, president, American Academy of Dermatology, in the press release. “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.”

Pending announcement of the results of a potential capital raise, Botanix intends to remain in halt until tomorrow at the latest.1

“We are very excited to provide a new option for the 10 million patients with primary axillary hyperhidrosis in the United States,” said Vince Ippolito, executive chairman, Botanix, in the press release. “As the first and only new chemical entity, Sofdra represents a new therapeutic approach for dermatologists to treat patients with this disabling medical condition.”


1. FDA approval of Sofdra™ - the first new drug for primary axillary hyperhidrosis. Botanix. June 20, 2024. Accessed June 20, 2024. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819259-6A1212299 

2. Axillary Hyperhidrosis Treatment Market Snapshot. Future Market Insights. Accessed June 20, 2024. https://www.futuremarketinsights.com/reports/axillary-hyperhidrosis-treatment-market

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