New Gel Reports Sweat-Busting Results
A new gel to fight excessive underarm sweating has been found to provide meaningful relief (i.e. a 2-grade improvement in the Hyperhidrosis Disease Severity Score). Thanks to everyone who participated in the research. Ready for more?
Brickell Biotech is developing this new hyperhidrosis treatment for underarm sweating. If FDA-approved, the gel now called BBI-4000 (containing an anticholinergic called sofpironium bromide) would provide a new, much-needed, non-invasive treatment choice for hyperhidrosis. Brickell Biotech is developing this novel hyperhidrosis treatment for both underarm and palm sweating (but the underarm studies are further along in the FDA process). Check out their impressive research pipeline here.
David Pariser, MD, Secretary and founding Board Member of the International Hyperhidrosis Society applaudes the announcement and has said, “The results of this Phase 2b study are terrific news for the hyperhidrosis community, which has been frustrated by the lack of effective and convenient treatment options. The possibility of a new treatment alternative that is topical, well-tolerated, effective, and non-invasive is truly exciting and would be welcomed amongst patients and physicians.”
In addition to Brickell’s clinical development of BBI-4000 in the United States, Kaken Pharmaceutical Co., Ltd. (“Kaken”) is planning to conduct clinical studies of the drug candidate in Japan in 2016. In 2015, Brickell signed an exclusive license and development agreement with Kaken for BBI-4000 in Japan and certain other Asian countries. This is great news for the global hyperhidrosis community.
Anticholinergics have long been used as treatments for excessive sweating but usually in the form of oral medications – which can cause disruptive side effects. An anticholinergic that’s applied directly to the skin would be a more precise, targeted way to deliver what’s already seen as an effective medication. Indeed, the recent clinical studies of Brickell’s formulation were designed to evaluate the safety, tolerability and efficacy of different concentrations of sofpironium bromide and found the treatment to be well-tolerated and effective -- providing statistically significant and clinically meaningful improvement in sweating symptoms.
What’s next? Phase 3 clinical trials in which the treatment will given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely. Phase 3 trials are necessary before FDA-approval and availability to the public. Keep watching this blog for updates on how you can be part of the important research and for information about when this new gel may become available. Sweaty fingers crossed!