Potential Medical Device for Underarms, Oral Hh Med Designed to Fight Side Effects, Qbrexza® News & Palmar Hh Study Recruiting
There is a lot of research going on related to the management of hyperhidrosis.
In Part 1 of the IHhS Hyperhidrosis Research & Treatment Pipeline Report we discuss the ongoing development of Brickell Biotech’s topical gel (sofpironium bromide/BBI-4000) for the potential treatment of underarm excessive sweating.
Here, we cover five cutting edge companies, five research studies, four excessive sweating treatments, and more. Read on for the hyperhidrosis news you don’t want to miss from Candesant Biomedical, Dermavant Sciences, Dermira/Lilly, Maruho, and Atacama Therapeutics.
Medical Device for Underarm Sweating in Development in San Fran
Candesant Biomedical of San Francisco, Calif. is working on a medical device that uses “water activated” technology to help treat underarm excessive sweating (axillary hyperhidrosis) in minutes. The treatment is given in a medical office via a patch that is applied to underarms for three minutes and delivers a dose of heat precisely to the sweat glands. The results, according to the company, are “in-activated” sweat glands, reduced sweating for about two months, and a 71% decrease in measured sweat. Six weeks after treatment, sweat remained 69% reduced. In terms of side effects, the company reports a few cases of mild and temporary redness or irritation. These side effects, says Candesant, were “well-tolerated.” (In medical research and development, the term “well-tolerated” typically means that the treatment did not cause very many users to drop out of the study.)
Candesant’s pipeline also includes similar products in development for palmar hyperhidrosis, plantar and facial hyperhidrosis, and an over-the-counter option. We’re keeping our ears and eyes open for updates.
Combo Oral Medication for Hyperhidrosis Aims to Limit Common Drawbacks Like Dry Mouth
Dermavant Sciences, a biopharmaceutical company based in Long Beach, Calif. is developing an oral treatment for primary multifocal hyperhidrosis that’s a combination of the medications oxybutynin and pilocarpine. The product candidate, currently called DMVT-504 (previously known as THVD-102) has finished Phase 1 trials. As you may know, Phase 1 trials are the first trials done with people to test a potential new treatment and to help determine its safety. Phase 1 trials also aim to find the most effective dose of a new drug, balanced with the fewest side effects. In total, three phases of clinical trials are required before the U.S. Food and Drug Administration (FDA) will evaluate a new treatment for potential approval for use by the public.
The oral medicine oxybutynin is already often prescribed to treat hyperhidrosis, but it is not FDA-approved for this indication (rather, it’s used “off label”). Oxybutynin, alone, can have side effects like dry mouth that limit its long-term practicality. DMVT-504 combines oxybutynin with a delayed-release version of another oral med called pilocarpine. Pilocarpine works to combat oxybutynin’s possible side effects. In other areas of medicine, pilocarpine is used to help manage dry mouth among cancer patients undergoing radiation therapy, dry mouth related to Sjögren’s syndrome, and increased eye pressure in glaucoma patients. It’s also sometimes used to help with severely dry eyes in people with Sjögren’s. The medicine comes from the leaves of plants found in South America.
In a clinical trial in primary focal hyperhidrosis (excessive sweating) on different/multiple body areas, DMVT-504 was shown to significantly decrease sweating without the bothersome dry mouth side-effect as compared to oxybutynin taken alone. According to Dermavant, the same results cannot be achieved by taking currently-available oxybutynin and pilocarpine meds together because regular formulations don’t include DMVT-504’s dosing technology for delayed release, among other things.
Look for more trials of DMVT-504 to hopefully begin soon. We are often involved in recruiting for clinical trials, so be sure you are subscribed to our news blog and watch your email for messages from us. If this combo-medication were to achieve FDA approval in the future, it would be the first FDA-approved oral (or “pill”) option for excessive sweating management.
More Qbrexza® Safety Data, Potential Hurdles for Qbrexza’s Use Beyond Underarms & COVID Contributions
As many of our readers know, Qbrexza® is the most recent (June 2018) FDA-approved treatment for underarm excessive sweating. Qbrexza is an anticholinergic applied to the skin of the armpits once per day using a medicated cloth. Additional research is now available regarding the tolerability of Qbrexza for the underarms. In a study published in January 2021 in the journal Clinical Pharmacokinetics, researchers found that the active ingredients in topical (applied on top of the skin) Qbrexza were not absorbed systemically into the body (i.e. beyond the underarms where the drug is designed to work) to the same degree as a similar medicine was when it was taken by mouth. The research also found a low risk of anticholinergic side-effects (like dry mouth or dry nose) with Qbrexza as compared to an oral version of the medicine.
IHhS is often asked whether Qbrexza may someday be available for use on other hyperhidrosis body sites, in addition to the underarms. Here’s what we know: While the makers of Qbrexza (Dermira, which was acquired by Eli Lilly and Company) have finished a study with 72 participants (A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis) using the cloths on the palms, the results have not yet been published. Results from another relevant study, however, are available. Published in the Journal of Drugs in Dermatology, this study looked at how Qbrexza might be absorbed through membranes of different thicknesses approximating the skin of different body areas, including hands, feet, underarms, and the abdomen. Note that this was a laboratory-based (in-vitro) study, not a study conducted on real people. Results showed that delivery of Qbrexza’s active ingredients through the “skin” of hands and feet could potentially be up to 40-times lower than delivery through underarm or abdominal “skin,” but occlusion (covering the surface with a non-breathable material) could help. More studies are needed to determine if there are options for Qbrexza beyond the underarms, and we’ll keep you posted of anything else we learn on the topic. In the meantime, remember that Qbrexza is currently only FDA-approved for the underarms, and is NOT meant to be occluded. Everyone using Qbrexza should follow its directions for use carefully.
To learn even more about Qbrexza-related research, visit our blog summarizing data presented at an American Academy of Dermatology Annual Meeting.
As mentioned above, the makers of Qbrexza (Dermira) have been acquired by pharmaceutical giant Eli Lilly and Company. Lilly is contributing to the global fight against COVID-19 in numerous ways. This includes working to help those who need its medications (especially insulin), but are (due to the pandemic) struggling to afford treatments. (On the topic of affordability, watch our blog and emails for information about how to better afford your hyperhidrosis treatments coming mid-2021!)
Lilly is also researching multiple treatments for COVID-19, and has received an Emergency Use Authorization for baricitinib for the treatment of patients hospitalized due to COVID-19 infection. To learn more about how Lilly is helping to combat COVID-19, click here.
Qbrexza Likely to Become Available in Japan
In more Qbrexza news, the Japanese company Maruho has licensed Qbrexza (as M6060) and is working on the Phase 3 trials necessary for Japanese approval of the topical cloths to treat underarm excessive sweating. Dermira and Maruho report that the prevalence of primary axillary hyperhidrosis in Japan is estimated to be approximately 5.75% of the population (or approximately 7.5 million people). That is a large number of hyperhidrosis sufferers who could potentially find help through Qbrexza in the future.
Oral Medicine Specifically for Palmar Hyperhidrosis
Atacama Therapeutics (Wellesley, MA) is a more recent entry into the hyperhidrosis world. The company believes their product could be useful in the treatment of palmar as well as other forms of primary hyperhidrosis, and reports successful completion of a Phase 2 clinical trial related to hyperhidrosis. Data is not yet available, however. We’re watching the journals and research conferences carefully and will update you as soon as we can.
In related research, Atacama has a clinical trial for palmar Hh listed here. Recruitment for the study site in Norfolk, Virginia seems to be ongoing. Consider reaching out to ClinicalResearch@therapeuticsinc.com to see if you might qualify.
The trial is looking at two different oral doses of AT-5214 (dexmecamylamine HCl) versus a placebo in patients with severe primary palmar hyperhidrosis (sweaty palms). Dexmecamylamine HCl is a single isomer of mecamylamine that inhibits α3β4 nicotinic receptors and is a nicotine acetylcholine antagonist.
What else is happening in hyperhidrosis research? Find out by reading all three parts 2021 Hyperhidrosis Research & Treatment Pipeline Report (located in our blogs). Heads-up: it includes TEN really interesting hyperhidrosis studies focusing on everything from new ways to use iontophoresis, lasers and botulinum toxin to manage excessive sweating that can be a complication of limb amputation. Love this type of work from us? Please support the International Hyperhidrosis Society so we can keep it coming.
Do You Want to Help with Hh Research?
For Hh sufferers, getting involved in research can be a potential path to treatment and a satisfying way to give back to the community that’s striving to make a difference in the excessive sweating sphere. To brush-up on the basics about clinical trials, click here.
For researchers and organizations conducting clinical, market or educational research, the International Hyperhidrosis Society is here to help. Whether your project is targeted or broad, get in touch to learn how we can make the process smooth, efficient, and successful. We have deep experience in refining protocols, ensuring a patient-centric approach, and improving participation, adherence and reliability. This, combined with our ability to make connections across the miles, across disciplines, and across the bench is central to all we do.
Motivated to read the latest medical journal articles and study outcomes related to hyperhidrosis so you’re totally in the know? Or, just want to catch up on the headlines of what’s happening in the world of sweat research? Be sure to visit the Published Scientific Research section on this website where we curate the most timely and relevant peer-reviewed pieces for you.
This report has been provided so you’re up-to-date on hyperhidrosis-related research that is underway. Please note that all of the information provided is publicly available, although not from one easily-digestable source. Until now! Donate to the IHhS and keep the info coming.