Sofdra™ Gel Gets OK from FDA 

Exciting news! The U.S. Food and Drug Administration (FDA) recently approved a new treatment for underarm excessive sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older. 

Even better news, this is a topical treatment that’s for home-use and applied directly to the underarm skin before bedtime. No needles. No aluminum. #KnowSweat

Called Sofdra, and made by Botanix Pharmaceuticals, the new treatment is a prescription anticholinergic medicated gel. It’s the first new, at-home, self-applied, and self-managed treatment for hyperhidrosis approved in the U.S. since 2018.

Sofdra Is Not Your Typical “Antiperspirant”

Although it is a topical gel applied to your underarms, Sofdra differs from antiperspirants in that it’s a medical treatment with stronger effects than antiperspriants. Sofdra also doesn’t contain aluminum and uses a different method of action than antiperspirants. Its active ingredient is sofpironium, which is an anticholinergic that blocks sweating at the sweat glands by interrupting sweat signals. Basically, it prevents sweat glands from becoming stimulated to “turn on.” And, because this medication is applied to the skin of the underarms, it works at the site of underarm sweating and targets those specific sweat glands. 

You are probably already familiar with anticholinergics as medications taken by mouth to treat excessive sweating. But when taken as pills, tablets or oral liquids, anticholinergics can have uncomfortable side effects like dry mouth, muscle cramping, and urinary retention, making them hard for some people to use. However, if an anticholinergic is applied directly to the skin, like with Sofdra, the likelihood and severity of such side effects can be greatly reduced. As a skin product, Sofdra is designed to work at the location where it’s applied (in the underarms) and not on the whole body. Some absorption by the body is, however, possible - which is why you should only apply Sofdra specifically as directed. Risks for side effects can increase if Sofdra is applied to other body areas or if someone uses Sofdra and also takes an oral anticholinergic or uses any other anticholinergic topical product. 

If you follow research and development in the excessive sweating world, you might recognize this product as one that Brickell Biotech had been working on before it was sold to Botanix in 2022. 

To use Sofdra, you apply the gel to your underarms with a special applicator before bedtime. The applicator is important because it helps prevent the medication from getting on your hands where it could be absorbed, or where it could transfer through touch to more sensitive areas like the mouth, nose or eyes. Using the applicator is, thus, critical for limiting side effects. 

Community Leaders Excited About Sofdra

“All of us at the International Hyperhidrosis Society are celebrating Sofdra’s approval,” says Lisa J. Pieretti, MBA, Executive Director of the International Hyperhidrosis Society (IHhS). “This could be a game-changing treatment and we are so proud that our patient community was instrumental in the studies that helped bring us to this moment. The hyperhidrosis experience varies from person to person and treatment is not one-size-fits-all, but we really think this innovation is a huge step forward.” 

“The approval of Sofdra is terrific news for the hyperhidrosis community,” adds David Pariser, MD, founding board member of the IHhS and former president of the American Academy of Dermatology. “Studies have shown that Sofdra is effective and easy to use for most people. It’s great to have it as an option for excessive sweating. I can already think of so many people who are going to appreciate this at-home, self-managed choice.” 

Key Sofdra Study Results

The active ingredient in Sofdra went through extensive studies in the U.S. prior to its FDA approval, including one with 300 participants that lasted almost a year (48 weeks). Two other studies lasted 2 months (per patient) and included more than 700 participants. Study volunteers were aged nine years and older, and all were diagnosed with primary axillary hyperhidrosis. 

Results showed that:

• 85% of patients using the sofpironium gel experienced a clinically meaningful improvement in their underarm excessive sweating
• More than 60% of study participants had a 50% or greater reduction in sweat production
• The most common side effects reported were:
  • Blurred vision (in 19% of users)
  • Dry mouth (in 17% of users)
  • Underarm skin itching (15%)
  • Underarm skin swelling or irritation (11%)
  • Underarm skin pain (8%)
  • Underarm redness (8%)
  • Dilated pupils of the eyes (5%)
  • Dry eyes (4%)
  • Urinary retention (4%) 

Four studies also looked at sofpironium gel for children aged 9 to 16 with underarm excessive sweating. Seventy-two young people participated and used sofpironium for different lengths of time (6 weeks, 24 weeks, or 48 weeks). In the studies, there were no severe or serious side effects reported and participants said they had meaningful improvement in their sweating. In explaining the changes in their sweating, most participants said they had approximately 65% improvement in their sweating severity. Two participants did, however, stop using the treatment due to dry eyes, dry mouth, itching, and rash. 

People Who Should Not Use Sofdra

Do not use Sofdra if you have certain medical conditions that can be made worse by taking an anticholinergic medicine. These conditions include:

• Glaucoma
• Severe ulcerative colitis (UC)
• Certain other serious bowel problems associated with severe UC
• Myasthenia gravis
• Sjogren's syndrome

Also, there have been concerns over the years about older patients taking anticholinergics for long periods of time and increased risks of dementia – these concerns may be reduced with Sofdra because this is a medicine delivered through the skin to the affected area and not taken by mouth. Older adults should, however, discuss Sofdra and anticholinergic effects with their healthcare provider.

Important Do’s and Don’ts of Using Sofdra

DO:

• Apply Sofdra before bedtime. 
• Wear a tank top or bra that’s low cut at the underarms or take off your shirt/bra before applying Sofdra.
• Dry underarms with a clean towel.
• Apply Sofdra with the applicator provided.
• Put your arms down and let Sofdra dry completely (takes about five minutes) before putting on pajamas, a robe, or other clothes.
• After application, rinse the applicator but avoid getting Sofdra on your hands.
• Wash your hands with soap and water.
• Leave Sofdra on your underarms for 8 hours.
• Contact your healthcare provider if you experience side effects like dry mouth, blurred vision, dilated pupils in the eyes, problems urinating, or irritated skin. 
• Talk to your healthcare provider before taking Sofdra if you use any other anticholinergic oral medications, such as atropine, benztropine, oxybutynin, or glycopyrrolate; or any other anticholinergic topical product; or if you are pregnant or breastfeeding, or plan to become pregnant or breastfeed; or if you have any bladder or kidney problems, or have problems passing urine.

DON’T:

• Shower, wash your underarms, or exercise within 30 minutes before applying Sofdra.
• Apply Sofdra to broken skin.
• Use your hands or anything except the provided applicator to apply Sofdra.
• Smoke or go near any open flame when applying Sofdra and until after Sofdra is dry. Sofdra is flammable. 
• Get Sofdra on your hands or on any other skin except in the armpits.
• Touch your underarms after applying Sofdra until it’s dry (wait about 5 minutes).
• Get dressed until Sofdra is dry. 
• Shower, shave, exercise (which induces sweating), wash your underarms, or apply any other products to your underarms (like deodorant) for 8 hours after applying Sofdra.

FAQs About Underarm Hair 

• It’s okay to use Sofdra on underarms with hair or new growth (like stubble). 
• Don’t shave until 8 hours after Sofdra application. 

There is a lot more to learn about Sofdra--including when it will be available--and we’ll continue to report on it in our news blog, so stay tuned!