New Treatment for Excessive Underarm Sweating Gets FDA Okay

As temperatures rise this time of year, many of us can expect to start sweating more than we may like to. While perspiration during hot weather is normal, some people have a condition that makes them prone to extreme sweating.

Called hyperhidrosis, this disorder is characterized by perspiration (from the underarms, palms, soles of the feet, head and face, and other areas) beyond what the body requires to regulate internal temperature.

Recently, the U.S. Food and Drug Administration (FDA) approved a new topical prescription treatment for a type of hyperhidrosis that results in excessive underarm sweating. The medication, called Sofdra (sofpironium) topical gel, 12.45 percent, is from Botanix Pharmaceuticals. Sofdra is approved for adults and children ages 9 and up.

Danilo C. Del Campo, MD, a dermatologist at the Chicago Skin Clinic, suggests that the medication may be especially effective for some patients because of its precise mechanism of action.

“Sofpironium bromide directly limits sweat production by inhibiting the communication pathway responsible for activating the sweat glands,” says Dr. Del Campo. “Nevertheless, each patient’s response to treatment will invariably differ.”

Hyperhidrosis Is Widespread but Under-Recognized

Sofdra was approved to treat a specific kind of hyperhidrosis called primary axillary hyperhidrosis. Another form of the disorder, called secondary hyperhidrosis, can be caused by certain underlying medical problems or as a side effect of certain drugs.

By some estimates, hyperhidrosis affects as many as 4.8 percent of Americans.

“Despite hyperhidrosis affecting millions, it remains under-recognized primarily due to social stigma and lack of awareness,” says Shoshana Marmon, MD, an assistant professor of dermatology at New York Medical College in Valhalla. “Many individuals feel embarrassed to discuss excessive sweating and may perceive it as a personal or hygiene issue rather than a medical condition.”

People who have the condition may brush it off as a natural response to sweltering heat, intense stress, or bouts of anxiety.

How to Recognize Hyperhidrosis

Do you perspire a lot? Here are a few of the signs of hyperhidrosis.

The sweat is visible. When you are not exerting yourself, do you often see beads of sweat on your skin or have sweat-soaked clothing? Do you sweat when you’re sitting?
Sweating interferes with everyday activities. Does sweating cause difficulty holding a pen, walking, or turning a doorknob? Does sweat drip heavily onto your papers or computer?
Skin turns soft, white, and peels in certain areas. Does your skin stay wet for long periods?
Skin gets infected. Do you get frequent skin infections on the parts of your body that sweat heavily? Athlete’s foot and jock itch are common complications of hyperhidrosis.

For those hit hardest by hyperhidrosis, sweating can interfere with simple tasks of daily life and cause a lot of stress and self-consciousness.

“Persistent and intense sweating can erode self-confidence, increase anxiety, and lead to isolation from social events,” says Del Campo. “It often hinders professional performance, as sufferers may become exceedingly self-aware during work engagements or in casual interactions. Routine tasks, like operating a touchscreen or gripping a steering wheel, can become obstacles.”

Sofdra Resulted in Significantly Less Underarm Sweating

Sofdra gained FDA approval after trials involving 701 patients with primary hyperhidrosis demonstrated clinically and statistically meaningful improvement in those taking the drug.

Sofdra topical gel treatment for excessive sweating — Botanix

Efficacy of Sofdra was measured in two ways, according to Botanix. One used a scale where patients rated their sweating from 0 to 4 on seven questions. Treatment success was measured as being an improvement of 2 or more points. At the end of the trial 60 percent of patients had a 2-point or more improvement.

The other measure of efficacy was sweat production, which dropped by 50 to 60 percent.

The medication joins an expanding roster of possible therapies for the condition. These include prescription antiperspirants as well as treatments involving the delivery of mild electrical current, botulinum toxin (Botox) injections, surgery, and anticholinergic medications — medications that block the action of acetylcholine, the neurotransmitter responsible for stimulating sweat glands.

Sofpironium is an anticholinergic drug. Because it is a gel that directly targets sweat production in a particular area rather than a pill that affects the whole body, it may cause fewer side effects like dry mouth and constipation than oral anticholinergics like glycopyrrolate, oxybutynin, and propantheline, according to Dr. Marmon.

“Until sofpironium came along, glycopyrronium tosylate (Qbrexza), approved by the FDA in 2018, was the only topical anticholinergic used for treating hyperhidrosis,” says Marmon. “How the drugs compare depends on individual response.”

Botanix intends to launch an “early patient experience program” in the third quarter of this year that will let some patients get early access to Sofdra, while a broader launch is planned for the fourth quarter of the year.