Sofdra™ Topical Gel for Primary Axillary Hyperhidrosis

sofdra logo 001ba3924dce716b193667645daa20d7In June 2024, the U.S. Food and Drug Administration (FDA) approved Sofdra to help treat underarm excessive sweating (primary axillary hyperhidrosis) in adults and children 9 years of age and older. Made by Botanix Pharmaceuticals, Sofdra is a prescription anticholinergic medicine applied to the skin of the underarms. It’s the first new, at-home, self-applied, and self-managed treatment for hyperhidrosis that has been FDA-approved since 2018.

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. Approximately 10 years of research and development went into Sofdra. 

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 antiperspirants. Also, Sofdra doesn’t contain aluminum, and it uses a different method of action than antiperspirants. Its active ingredient is sofpironium (sofpironium 12.45% also known as sofpironium bromide 15%), 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. 

The active ingredient in Sofdra (sofpironium 12.45%/sofpironium bromide 15%) is a new chemical formulation, with a unique structure. The biological binding site and effects are anticholinergic, but it is structurally different from other anticholinergic drugs on the market. 

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 systemic (or whole body) side effects like dry mouth, muscle cramping, and urinary retention, making them hard for some people to use. If, however, an anticholinergic is applied directly to the skin, as 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 it with any other anticholinergic topical product. 

To use Sofdra, you apply the gel to your underarms with a special applicator. 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. 

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, each lasting two months per participant, included more than 700 people. 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. Sofdra is an alcohol-based gel and dries very quickly. The purpose of the 5-minute wait-time is to prevent the inadvertent wiping off of the gel onto clothing which could reduce the amount of product applied. The product is clear and should not stain clothing.
  • 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. (It is ok to apply a deodorant or antiperspirants 8 hours after application of 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. 

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 lower strength product (5% concentration) for patients with primary axillary hyperhidrosis (underarm excessive sweating). 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 Ecclock or a placebo gel to their underarms for 42 days. All of the people 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 using Ecclock 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 Ecclock group were nasopharyngitis (cold symptoms, 14.2%), dermatitis (itchy, red or rashy skin) in the underarms (8.5%), and erythema (redness) 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 (dilation of the pupils of the eye) (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!

Next Steps

Have you talked to your provider about excessive sweating? If not, now is the time! Learn more about how you and your healthcare team can work together to find the right treatment, or combination of treatments, to manage your hyperhidrosis.

Are you interested in trying Sofdra for axillary hyperhidrosis? Our Clinician Finder can help you locate practitioners who treat hyperhidrosis. We also have information and resources to help you prepare for your appointment.

Have an informed discussion with your healthcare team by learning about all of the available treatment options for each of these body areas that may be affected by excessive sweating:

And remember, because hyperhidrosis is a serious medical condition - you deserve insurance coverage and reimbursement for your medical visits and treatment.  We've got tips to help you navigate the health insurance realm; visit Insurance Tools for more information. 

Finally, you may want to consider participating in a clinical trial. Patients enrolled in clinical trials often receive treatments free of charge. Visit our Active Research page to find out more, and whether you're eligible to participate in the latest studies.

For the latest news about treatments, clinical trials, and special events, sign-up for our free blog. And please help to support our work by:

 *A life-threatening adverse event, or serious side effects is defined as: inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

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