Sofpironium Topical Gel Approved by FDA for Primary Axillary Hyperhidrosis

sofdra logo 001ba3924dce716b193667645daa20d7Sofdra™ for Underarm Excessive Sweating

In June 2024, the U.S. Food and Drug Administration (FDA) approved Sofdra to help treat primary axillary hyperhidrosis in adults and children 9 years of age and older. Made by Botanix Pharmaceuticals, Sofdra is a prescription topical anticholinergic. It’s the first new, at-home, patient-applied treatment for axillary hyperhidrosis that has been FDA-approved in the U.S. since 2018.

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

Sofdra contains active ingredient sofpironium 12.45%. Sofpironium is an anticholinergic/antimuscarinic medication that blocks sweating at the level of the sweat glands by interrupting sweat signals. Sofpironium is a competitive inhibitor of acetylcholine receptors that are located on certain peripheral tissues, including sweat glands.

Sofpironium bromide indirectly reduces the rate of sweating by preventing the stimulation of these receptors. Patients apply the gel to the underarms with an applicator designed to help prevent the medication from getting on the hands.

Sofdra also does not contain aluminum.

Key Sofdra Study Results

Sofdra went through extensive studies in the U.S. prior to its FDA approval. Two pivotal trials (“Cardigan I” and “Cardigan II”) lasted eight weeks (per participant) and included about 350 hyperhidrosis sufferers each. Study volunteers were aged nine years and older and were diagnosed with primary axillary hyperhidrosis. 

Results showed that:

  • 85% of patients using the sofpironium gel experienced a clinically meaningful improvement in their condition.
  • More than 60% of study participants had a 50% or greater reduction in sweat production.
  • The most common side effects reported were dry mouth and blurred vision. These were usually mild or moderate and temporary. 
  • There were no treatment related serious adverse events in any of the studies.

Studies also looked at the use of sofpironium for children aged 9 to 16 suffering from primary axillary hyperhidrosis (underarm excessive sweating). The young people with hyperhidrosis in this study used sofpironium for more than 5 months with no severe or serious side effects and reported meaningful improvement in their underarm sweating symptoms (an approximately 65% improvement in how they initially described their sweating severity). Two participants did, however, stop using the skin treatment due to dry eyes, dry mouth, itching, and rash. 

People Who Should Not Use Sofdra

Avoid coadministration of Sofdra with other anticholinergic-containing drugs (both oral and topical). Coadministration of Sofdra with other anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. 

Patients with medical conditions that can be made worse by taking an anticholinergic medicine should not use Sofdra. These conditions include:

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

Consider, also, 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 of its topical administration rather than oral administration, but further thought may be required. 

Important Do’s and Don’ts for Sofdra Use

Before prescribing Sofdra, discuss with patients:

  • All of their medical conditions and whether they are using another oral or topical anticholinergic medication, or not.
  • Any bladder or kidney problems, or if there are problems passing urine.
  • If a patient is pregnant or breastfeeding, or plans to become pregnant or breastfeed. 

Patient Do’s:

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

Patient Don’ts: 

  • Shower, wash underarms, or exercise within 30 minutes before applying Sofdra.
  • Apply Sofdra to broken skin.
  • Use 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 hands or on any other skin except in the armpits.
  • Touch 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 underarms, or apply any other products to 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). 
  • Shaving should be avoided until 8 hours after Sofdra application. 

Most Common Side Effects of Sofdra

  • Dry mouth
  • Blurred vision
  • Pain, redness, swelling, itching, and irritation in the underarm area
  • Mydriasis
  • Problems with urination 

Ecclock® Sofpironium Bromide 5% Available in Japan

Of note, a similar product (Ecclock) was approved in Japan in 2020 and launched by Botanix’s partner, Kaken Pharmaceutical Co., Ltd. 

Ecclock is a 5% concentration for patients with primary axillary hyperhidrosis. Kaken also has rights to develop and commercialize sofpironium bromide in Korea, China, and certain other Asian countries. It is expected to be available in Korea first. 

Phase 3 study results for Ecclock were shared as late-breaking research at the 2020 American Academy of Dermatology Virtual Annual Meeting and in the Japanese Dermatological Association’s Journal of Dermatology. In the research, 281 Japanese patients were randomized to either apply sofpironium bromide gel 5% or a placebo gel to their underarms for 42 days. All of the subjects involved in the study had baseline Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or higher and measurements of sweat production per minute of 50mg or above. At the end of the study, 54% of participants had improved HDSS scores (down to 1 or 2 from previous scores of 3 or more) and 50% reduction in their sweat production measurements (as compared to 36% with placebo.)

Common, mostly mild side effects (occurring in 5% or more of patients) in the sofpironium bromide gel group were nasopharyngitis (14.2%), dermatitis in the underarms (8.5%), and erythema at the application site (5.7%). Also, a small percentage of those (2.8%) in the treatment group experienced anticholinergic-class side effects such as dry mouth (1.4%), constipation (0.7%), and mydriasis (0.7%).

There is a lot more to learn about Sofdra and we’ll continue to report on it in our news blog, so make sure you subscribe and stay tuned!

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