Something to Smooth on Your Skin or Pop in Your Mouth? New Meds You Haven’t Heard About (Yet) Could Change Everything
What’s the biggest news in hyperhidrosis that no one is talking about?
Novel treatments for hyperihidrosis in development! They aren’t FDA approved (yet) but there are some promising clinical results (some might even say potentially life-changing).
Anticholinergic Skin Wipes from Dermira
Dermira, a biopharmaceutical company based in Menlo Park, CA, recently released new data about its axillary (underarm) hyperhidrosis treatment candidate glycopyrronium tosylate, designed to block sweat gland activation. This potential new therapy is a once-daily anticholinergic that’s applied onto the skin (topically) with a wipe. Just-out results show that it can improve sweating symptoms as soon as 1 week after starting the regimen. Dr. Glaser, one of our co-founders and board members, worked on this clinical trial and says that more and more dermatologists are becoming interested in treating hyperhidrosis given that there are greater options to help patients, currently and to come in the future.
Prior studies found that patients using glycopyrronium tosylate wipes once daily for four weeks improved their “sweating severity” by nearly 25% to 30% (compared with 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.
Dermira intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis in the second half of this year.
If it makes it through the rigorous FDA process, topical glycopyrronium tosylate could provide a great new option for its approved purpose (expected to be primary axillary hyperhidrosis) but may also be considered by physicians for possible “off-label” use to treat other excessively sweaty body areas.
Our 2¢? This may make a great non-invasive, flexible treatment option for teens. There are SO many hyperhidrotic adolescents out there needing help. International Hyperhidrosis Society research presented at the prestigious American Academy of Dermatology’s Late-Breaking Research Symposium shows that 17% of teens report excessive sweating!
By-Mouth Treatment with Less Dry Mouth from TheraVida
Another promising treatment in development comes from TheraVida in San Mateo, CA.
TheraVida’s THVD-102 combines the oral medicine oxybutynin (which is sometimes used to treat hyperhidrosis, but can have dry mouth and other side effects that limit its long-term acceptability) and a delayed-release version of pilocarpine. Pilocarpine works to combat oxybutynin’s side effects, especially bothersome, often "can't-stick-with-this" dry mouth.
Taken twice a day, THVD-102 has been shown to limit sweating and to reduce dry mouth to a statistically significant degree as compared to oxybutynin taken alone. TheraVida representatives indicate that the same results cannot be achieved by taking currently-available oxybutynin and pilocarpine meds together because regular formulations don’t include THVD-102’s proprietary technology, which enables pilocarpine’s delayed release and custom dosing to reduce the frequency and severity of dry mouth and, possibly, other side effects.
In new data published in the Journal of Drugs in Dermatology, there were not statistically significant differences between THVD-102 and oxybutynin in effectiveness as a hypehidrosis treatment. But, fewer subjects reported moderate to severe dry mouth while receiving THVD-102 compared to oxybutynin and more subjects categorized their dry mouth as “none” or “mild” while receiving THVD-102 compared to oxybutynin. These dry mouth differences were statistically significant. Dr. David Pariser, International Hyperhidrosis Society co-founder and winner of the American Academy of Dermatology’s top honor (the Gold Medal) is lead author on this paper.
If approved, physicians could choose to use THVD-102 for both primary and secondary hyperhidrosis and it could be good option for patients with multifocal hyperhidrosis (excess sweating of several body parts or more), too. Some of these uses may be “off-label” but would certainly be exciting new options, especially because our research (published in the peer-reviewed journal Dermatologic Surgery) shows that that 82% of hyperhidrosis sufferers have multifocal excessive sweating!
As far as we know, THVD-102 is the only oral, systemically-acting drug for hyperhidrosis currently in the development.
TheraVida and Dermira donate to the International Hyperhidrosis Society’s not-for-profit programs through unrestricted grants and their research shows a commitment to finding much-needed, flexible treatment options for a range of hyperhidrosis experiences.