FDA Gives Go-Ahead to Single-Use Sodium Patch to Combat Underarm Sweat

Candesant Biomedical’s adhesive patch for heavy underarm perspiration has been approved by the FDA just in time for the summer. The patch is designed in a way that it reduces underarm sweat for as long as a few months after only a few minutes of application.

According to the Mayo Clinic, contemporary treatments for excessive sweating include antiperspirants, wipes, and lotions available by prescription, as well as drugs intended to block neurons or as antidepressants, and recurrent Botox shots. The Brella SweatControl patch is intended to serve as an alternative, noninvasive remedy for perspiration.

In adults, the sodium patch has been approved for the treatment of primary axillary hyperhidrosis, a disease characterized by underarm perspiration that is profuse but not necessarily triggered by heat or activity. According to Candesant’s research, the true prevalence of hyperhidrosis is likely significantly higher than the 15 million people who have admitted to having the ailment. The condition frequently goes unreported, which causes it to go undiagnosed.

Niquette Hunt, founder and CEO of Candesant, said in a statement on Thursday that the FDA approval will make the patch available to the millions of individuals who suffer from hyperhidrosis, or excessive sweating above and beyond what’s necessary to keep the body cool.

Candesant is providing the Brella patch to certain aesthetic clinics around the U.S. as part of an “early experience program” ahead of its official release later this summer. After that, it will reportedly be rolled out nationally over the whole country.

During an office visit, doctors will place the patch on the patient’s underarm and leave it there for up to three minutes. Candesant’s “targeted alkali thermolysis” (TAT) technology provides the basis for these therapies. The company claims that the chemical reaction that occurs when sweat droplets land on the sodium patch generates a surge of thermal energy because sodium produces heat when it interacts with water.

This energy is then redirected into the sweat ducts, where it causes a “micro-thermal injury” with the goal of temporarily stopping perspiration production from the glands for a few weeks.

110 people with hyperhidrosis were enrolled in a recent study of the Brella patch; they were randomly assigned to receive either the sodium patch or a dummy patch on both underarms. The Hyperhidrosis Disease Severity Scale (HDSS) ratings of 64% of those treated with the Brella patch decreased to a 1 or 2 (starting from 3 or 4) by four weeks following therapy, compared to 44% of those in the control group. Overall, over 40% of Brella users reported a two-point decline in their HDSS ratings, whereas just 16% of sham patch users saw a similar drop.

In a five-minute period, the Brella group witnessed a reduction of 57 milligrams of gravimetric sweat, whereas the control group saw just an 18-milligram decrease.

Candesant claims that the reduction in sweating seen by Brella patch users lasts for at least three months for some users.

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