The U.S. Food and Drug Administration (FDA) approved Sofdra™ (sofpironium) topical gel, 12.45%, the first new drug approved to treat primary axillary hyperhidrosis (excessive underarm sweating) in both adults and children as young as 9 years old. This marks a milestone for millions living with this underrecognized dermatologic condition and is the first and only new chemical entity specifically developed and approved for this indication. Marshall Morris, Partner at DelRicht Research, emphasized the significance of the approval for patients who have long lacked safe, effective solutions for this condition.

A First-of-Its-Kind Topical Option for Excessive Sweating

Sofdra, developed by Botanix Pharmaceuticals, offers a safe, effective, and convenient topical alternative for patients who previously had limited or burdensome treatment options. Delivered as a once-daily gel, Sofdra demonstrated statistically significant improvements in sweat production and symptom severity in two pivotal Phase 3 trials, known as the CARDIGAN studies. The trials enrolled 701 patients and confirmed both the clinical efficacy and tolerability of the formulation across primary and secondary endpoints.

The most common side effects reported were mild and manageable, including dry mouth, blurred vision, and localized underarm irritation. Sofdra is expected to become commercially available in the U.S. in Q4 2024, following the company’s early patient experience program.

DelRicht Investigators Play a Role in Landmark Approval

DelRicht Research is proud to recognize Dr. Deirdre Hooper and Dr. Sarah Jackson of Audubon Dermatology in New Orleans, LA, who contributed as principal investigators in the Sofdra clinical trial program. Together, Drs. Hooper and Jackson have led more than 90 clinical trials with DelRicht since 2016 across a wide range of dermatologic and immunologic indications.

Their leadership and continued commitment to advancing dermatology research played a meaningful role in bringing this important treatment to approval.

Marshall Morris on Improving Quality of Life for 10 Million Americans

Hyperhidrosis affects an estimated 10 million people in the United States, often interfering with work, social activities, and emotional well-being. Until now, many patients lacked access to effective, tolerable treatment options that fit into their daily lives.

“Sofdra’s approval marks a major step forward for patients who have been underserved for far too long,” said Marshall Morris, Partner at DelRicht Research. “We’re honored to have supported this pivotal study alongside some of the most respected dermatology investigators in the country. This is exactly the kind of impactful innovation our teams strive to support every day.”

“Sofdra’s approval marks a major step forward for patients who have been underserved for far too long. We’re honored to have supported this pivotal study alongside some of the most respected dermatology investigators in the country. This is exactly the kind of impactful innovation our teams strive to support every day.”

— Marshall Morris, Partner at DelRicht Research

Learn More About Sofdra

Botanix expects the first patients to gain access through their early experience program in late 2024, with full commercial launch to follow shortly after. For more information on Sofdra’s clinical profile, safety, and upcoming availability, visit www.botanixpharma.com.

DelRicht Research remains committed to accelerating access to new therapies by delivering high-quality data, strong enrollment, and operational excellence across every study we support.

Read the full press release from Botanix.