Health

FDA Approves New Treatment For Excessive Underarm Sweating

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As temperatures rise, many people find themselves sweating more, a natural response to the heat. However, for some individuals, excessive sweating goes beyond what’s needed to cool down the body, causing significant discomfort and disruption in their daily lives.

This condition, known as hyperhidrosis, affects millions of people worldwide. Hyperhidrosis is characterized by excessive perspiration in areas such as the underarms, palms, soles of the feet, face, and other body parts, far beyond what the body requires to regulate internal temperature.

Recently, a new treatment for hyperhidrosis received approval from the U.S. Food and Drug Administration (FDA). This new medication, called Sofdra (sofpironium), is a topical gel that offers hope for those dealing with the challenges of excessive underarm sweating, also known as primary axillary hyperhidrosis.

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.”

What Is Hyperhidrosis?

 Hyperhidrosis is a condition where individuals sweat excessively, often in specific areas of the body, even when not physically exerting themselves or in a hot environment. There are two main types of hyperhidrosis: primary and secondary.

Primary hyperhidrosis occurs without any underlying medical condition and tends to affect specific areas of the body. In contrast, secondary hyperhidrosis is caused by another medical condition or is a side effect of certain medications.

Though estimates suggest that up to 4.8 percent of Americans experience hyperhidrosis, it often goes undiagnosed and untreated.

“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 Collegein Valhalla.

“Many individuals feel embarrassed to discuss excessive sweating and may perceive it as a personal or hygiene issue rather than a medical condition.”

Recognizing he Signs of Hyperhidrosis

Hyperhidrosis can manifest in various sways, and individuals may not immediately realize that their excessive sweating is a medical condition. Here are some signs:

  • Visible Sweat: Excessive sweating can be noticeable, even when not engaged in physical activity. You may often see beads of sweat on your skin, or your clothes may be drenched without a clear reason.
  • Interference with Daily Activities: Hyperhidrosis can make everyday tasks challenging. For example, excessive sweat on the hands can make it difficult to hold a pen, turn a doorknob, or use a touchscreen device.
  • Skin Issues: Prolonged exposure to moisture can cause the skin to become soft, white, and prone to peeling. Additionally, constant dampness can lead to frequent skin infections, such as athlete’s foot or jock itch.

For those dealing with hyperhidrosis, these symptoms can significantly affect their quality of life.

“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.”

New Treatment Option: Sofdra Gel

Sofdra (sofprionium) is a newly approved prescription treatment for primary axillary hyperhidrosis. It’s a topical gel that directly targets the sweat glands, offering a more localized and potentially less invasive option compared to systemic treatments.

“Sofpironium bromide directly limits sweat production by inhibiting the communication pathway responsible for activating the sweat glands,” explains Dr. Del Campo.

Because it is applied topically, Sofdra may cause fewer side effects than oral treatments, such as dry mouth and constipation, which are common with other anticholinergic medications.

Sofdra’s approval follows a clincal trial involving 701 patients with primarily hyperhidrosis. The results showed significant improvement in those who used the gel, with sweat production reduced 50 to 60 percent. Additionally, 60 percent of patients experienced a 2-point or more improvement in their self-reported sweating severity on a scale from 0 to 4.

“Sofpironium is an anticholinergic drug,” explains Dr. Marmon. “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.”

The Growing Range of Treatments for Hyperhidrosis

Sofdra joins a growing list of treatments for hyperhidrosis, including prescription antiperspirants, botulinum toxin (Botox) injections, and electrical therapies. While some of these treatment provide temporary relief, others offer more long-lasting solutions. Each patient’s response to these treatments can vary, so it is essential to work with a healthcare provider to determine the best option.

Prior to the approval of Sofdra, the only other FDA-approved topical anticholinergic was glycopyrronium tosylate (Obrexza), approved in 2018. While these treatments share similarities in their mechanisms, individual responses may differ.

“How the drugs compare depends on individual response,” says Dr. Marmon.

Looking Ahead: Sofdra’s Availability

Botanix Pharmaceuticals, the company behind Sofdra, plans to launch an “early patient experience program” in the third quarter of this year, giving some individuals early access to the medication. A broader release is expected in the fourth quarter.

For those struggling with hyperhidrosis, Sofdra offers a promising new treatment option. As more therapies become available, individuals suffering from excessive sweating can look forward to better management of this often-underrecognized condition, improving both their physical comfort and mental well-being.