In June 2018, the U.S. Food & Drug Administration (FDA) approved a new prescription topical treatment for axillary hyperhidrosis (underarm excessive sweating) called Qbrexza. Qbrexza is made by the biopharmaceutical company Dermira, Inc. of Menlo Park, Ca. It is scheduled to become available starting October 2018.
International Hyperhidrosis Society founders and board of directors members Dr. Dee Anna Glaser (St. Louis School of Medicine), Dr. Adelaide Hebert (University of Texas Medical School at Houston), and Dr. David Pariser (Eastern Virginia Medical School and Pariser Dermatology Associates) were involved in studying the safety and effectiveness of this new treatment and we congratulate them on its FDA-approval. It marks the first FDA sanctioning of a hyperhidrosis treatment since miraDry was FDA-cleared for use in the underarms in 2011 and since Botox® was FDA-approved in 2004.
Qbrexza (pronounced kew brex' zah) comes in individually packaged cloths (or wipes) that are to be used at home once per day to reduce underarm sweating. One wipe is intended for two underarms. The treatment works by blocking receptors responsible for sweat gland activation. In studies, Qbrexza was found to be effective and well-tolerated, even in children as young as 9 years old.
The active ingredient in Qbrexza is glycopyrronium tosylate, an anticholinergic formulation. As you may know, some hyperhidrosis sufferers take oral anticholinergics to help control their sweating, but can experience side effects such as: dry mouth, muscle cramps, and urinary retention. In theory, by applying the medication to the top of the skin instead of taking it by mouth, there may be a reduced incidence of such side effects. 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, again, be reduced with Qbrexza because this is a medicine delivered through the skin to the affected area and not taken by mouth. One dermatologist agrees saying, “Yes, the topical agent lessens the risk of dementia in older adults.” Discuss it with your healthcare provider and find out what he or she thinks.
In research studies with Qbrexza, the most common side effects were:
- Dry mouth (in 16.9-24.2% of patients)
- Erythema/area redness (in 17% of patients)
- Burning/stinging (in 14.1% of patients)
Qbrexza was shown in clinical trials to improve sweating symptoms as soon as 1 week after starting the regimen. Studies also found that patients using Qbrexza wipes once daily for four weeks improved their “sweating severity” by nearly 25% to 30% (compared to 4% to 5% with placebo) and that measured sweat volume was reduced by 50% or more (in most patients.) The wipes were "well-tolerated" and any reported side effects were primarily mild to moderate (see above).
Of special note, Qbrexza is FDA-approved for patients who are 9 years old or older. We have long discussed on this website how there are few approved treatments for children and teens with hyperhidrosis. As Qbrexza is a non-invasive, at-home option that is actually approved for kids, it may lead to meaningful, practical relief in this under-served group.
Dr. Dee Anna Glaser, Dermatology Professor and Interim Chair at the St. Louis School of Medicine and IHhS co-founder, says “This is a great addition to the treatments that we have for hyperhidrosis and based on my work in the clinical trials and feedback from study subjects, I am excited to offer this option to my patients. Moving forward, I hope there will be future investigation on the use of this therapy in nonaxillary hyperhidrosis, as well.”
Some questions, however, still remain:
- How much will Qbrexza cost and will health insurance policies cover it? Will healthcare policies require patients to try and fail with other hyperhirosis treatments before covering Qbrexza? Will any insurance tools or financial assistance be made available?
- Given that the current FDA-approval is for underarms only, will Dermira seek further approval for other body locations where excessive sweating is common? We hear from patients all the time that hands, feet, faces, back, groin/buttocks, and under the breasts are areas of unmet need.
- Will healthcare providers feel that it is appropriate to use Qbrexza “off-label” for other body areas? As we know, Botox is only FDA-approved for hyperhidrosis of the underarms and is often used for other purposes. And oral anticholinergics are not FDA-approved for hyperhidrosis treatment, but are often prescribed off-label for excessive sweating patients. We have already heard from multiple dermatologists who think there will “certainly” be off-label use of Qbrexza, but one cautions that facial use may run the risk of getting the treatment in the eyes and that the skin on the hands and feet may be too thick for adequate absorption of the active ingredients. We wonder whether the back, inner legs, or under the breasts would be good targets for Qbrexza? We’ll report more on this as we get additional feedback.
- Will Qbrexza be available outside of the U.S.? Will Dermira, Inc. seek the equivalent of FDA-approval elsewhere in the world? Such as from the European Medicines Agency (EMA), Central Drugs Standard Control Organization (CDSCO) in India, the PMDA in Japan, or the Medicines and Healthcare products Regulatory Agency of the United Kingdom?
- There is a warning in the Qbrexza prescribing information about transient blurred vision. How often does this happen and how soon after Qbrexza application?
- There is also a warning about risks of overheating while using Qbrexza. Would this make Qbrexza a poor choice for athletes, student-athletes, and anyone working outside in hot weather?
- Can Qbrexza be used with other hyperhidrosis treatments such as antiperspirants or Botox? (We know it’s not recommended to be used with oral anticholinergics.)
Talk to your healthcare provider about whether Qbrexza might be a good choice for you, or not. Be sure to mention any other medications you are using including over-the-counter products.
To learn more, review all the Qbrexza studies just posted in our published literature website section (look for glycopyrronium tosylate in the title) and watch this website for updates as we try to get answers to the questions that remain.
Have you talked to your doctor about excessive sweating? If not, now is the time! Learn more about how you and your doctor can work together to find the right treatment, or combination of treatments, to manage your hyperhidrosis.
Are you interested in trying Qbrexza for hyperhidrosis? As mentioned above, our Physician Finder can help you locate physicians who treat hyperhidrosis. Use it today!
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.
And remember, because hyperhidrosis is a serious medical condition - you deserve insurance coverage and reimbursement for your doctor's visits and treatments, We've got tips to help you navigate the health insurance realm; visit Insurance Tools for more information.
Research and References
Ready to learn more about Qbrexza for the treatment of excessive sweating? Here are links to relevant scientific research:
Glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: pediatric subgroup analyses from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials. American Academy of Dermatology meeting
Topical glycopyrronium tosylate (DRM04) for the treatment of primary axillary hyperhidrosis: pooled results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials. American Academy of Dermatology meeting
Glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: prior treatment analyses from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials. American Academy of Dermatology meeting.