FDA Approves New 3-Minute Treatment for Excessive Underarm Sweating

This patch, worn for 3 minutes in a doctor’s office, can help reduce extreme perspiration for up to 4 months.

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doctor applying patch to patient's underarm
The patch works by creating “microthermal injuries” to the sweat glands.Candesant Biomedical

People with excessive underarm sweating now have a new way to minimize their symptoms: The U.S. Food and Drug Administration (FDA) has approved Brella, an underarm patch applied temporarily in a doctor’s office that can curb perspiration for up to four months.

Brella is approved for adults with primary axillary hyperhidrosis, or excessive underarm sweating that isn’t always related to heat or exercise, its developer Candesant Biomedical said in a statement.

“FDA clearance of Brella represents a significant advance for millions of people dealing with the physical, emotional, financial, and aesthetic impact of hyperhidrosis, or sweating beyond what’s needed to keep the body cool,” Niquette Hunt, the founder and chief executive officer of Candesant, said in the statement.

Brella is a prescription sodium patch with an adhesive overlay that’s applied to the underarms in a doctor’s office. Wearing the patch for up to three minutes can reduce excessive sweating for three to four months, the company said. It works by triggering a reaction between sodium in the patch and water in sweat to cause what’s known as “microthermal injury” to sweat glands. This means less sweat until the effects of the patch wear off.

Brella Reduced Hyperhidrosis Sweating in Clinical Trials

Hyperhidrosis-Treatment-Brella
Candesant Biomedical
In a late-stage clinical trial used to seek FDA approval, 110 adults with excessive underarm sweating were randomly assigned to receive up to three minutes of underarm treatment with either Brella or a sodium-free sham patch. Participants were evaluated weekly for 12 weeks, then people who responded to treatment were followed for an additional 24 weeks.

While results of the trial haven’t been published yet, the company said that participants who received Brella had significantly less sweat production and improved quality of life. There were no serious or severe side effects reported, the company said.

People with hyperhidrosis can experience significant psychological and social impairment because of their condition. A review in January 2023 by the American Journal of Clinical Dermatology found that hyperhidrosis was associated with higher levels of depression and anxiety, and that stress in social situations can create a negative feedback loop that induces more sweating and embarrassment.

Prevalence and Treatment Options for Hyperhidrosis

More than 15 million adults in the United States have hyperhidrosis, and roughly 70 percent of these people have severe excessive sweating in at least one area of their body, one study found. Because only about half of patients discuss this issue with their doctor, it’s possible that the problem may be far more widespread, the study authors noted.

Other treatments for excessive underarm sweating include Botox injections, which block nerve signals that activate sweat glands, and MiraDry, a device that uses thermal energy to permanently eliminate sweat glands. There is also the oral medication option glycopyrrolate, but this can cause unpleasant side effects like heart palpitations, dry mouth, and headaches.

These alternatives for excessive underarm sweating aren’t always effective, and they can also have unpleasant side effects and be quite expensive for patients, says Maral Kibarian Skelsey, MD, the director of the Dermatologic Surgery Center of Washington and a clinical associate professor at Georgetown University School of Medicine in Washington, DC.

Side effects of Botox can include problems swallowing, speaking, or breathing, according to the company website. Patients opting for MiraDry, which can cost $2,000 to $3,000 per session and require up to three sessions, may experience underarm swelling, redness, and tenderness, as well as numbness or tingling in the armpit. Local anesthesia to receive treatment may be needed.

“Brella may be easier to utilize,” says Dr. Skelsey. “It doesn’t need to be applied every day, doesn’t require painful injections, and in trials there were few side effects. The approval is a boon to patients who may not have responded to other therapies or who want to avoid the pain or side effects of other available options.”

Candesant expects the treatment to become available in late summer 2023. The company has not yet released pricing information.