PracticeUpdate Dermatology Best of 2018

AAD 2018 31

Topical Anticholinergic Offers NewOption for the Treatment of Axillary Hyperhidrosis Phase II study with “soft” molecule sofpironium bromide shows good efficacy and tolerability. A phase II multicenter trial examining the use of three concen- trations of sofpironium bromide for the treatment of axillary hyperhidrosis has shown efficacy in both patient-reported and objective outcomes measures. The study was presented at the AAD meeting. experienced both a 50% of greater reduction in GSP as well as an improvement in HDSM-Ax of at least 1 point, which was also significantly more than the 38.6% of patients who used the vehi- cle alone (P < .0154). Results were almost identical among patients taking the highest concentration of the agent, in whom 59.3% achieved this outcome (P < .0181 vs vehicle).

Presenter Stacy Smith, MD, from the Univer- sity of California, San Diego as well as the California Dermatology & Clinical Research Institute, told Elsevier’s PracticeUpdate that currently available treatments of axillary hyperhidrosis have their limitations. Prescrip- tion strength aluminum chloride products have limited efficacy. Axillary injections of botulinum toxin, while more effective, are expensive, unpleasant, require repeat treat- ments, and are unlikely to be reimbursed by

The change in GSP by ranked value was 16.68 in the 5% group and –27.85 in the 15% group, both of which were significantly greater than the +6.54 seen with the vehicle (P < .0361). All doses of the drug were safe and well-tolerated, with 29.8% reporting at least one adverse event in the 5% group and 51.9% in the 15% group, compared with 15.8% among those using the vehicle. These were predominantly mild to moderate in severity and resolved spontaneously following treatment. “A treatment like this one represents a very simple, easy-to-use [option with] very good safety, efficacy, and value for the patient,” said Dr. Smith. “When topical anticholinergics become available as commer- cial prescription products like this, it will change the landscape,” he predicted. “These will almost certainly become the first go-to agents.” While he expects dermatologists to adopt them first, he also anticipates that primary care physicians will use them even- tually “because the risk–benefit profile is pretty darn good.” Manufacturer Brickell Biotech is currently planning a phase III trial using both the 5% and 15% concentrations of sofpironium bromide in order to obtain FDA approval of the product for use in axillary hyperhidrosis. www.practiceupdate.com/c/64731

Dr. Stacy Smith

medical insurance. It can also trigger compensatory hyperhidro- sis, he said, in which other parts of the body begin to perspire excessively. Anticholinergic agents can be effective treatments, but side effects, particularly dry mouth, urinary retention, and blurred vision, greatly limit oral therapy, said Dr. Smith. Several topical anticho- linergic treatments are currently in development, but sofpironium bromide is unique in that it is a “soft” molecule, meaning it, “breaks apart quickly and breaks apart under the influence of the meta- bolic systems of the body,” explained Dr. Smith. “What you want is something that acts locally but not systemically, and that is what a soft molecule does. You can put it on, get localized activity in the

axillae and minimize the activity elsewhere.” Dr. Smith and colleagues at 23 different sites randomized 227 patients with axillary hyperhidrosis equally to treatment with sofpironium bromide gel at a concentration of 5%, 10%, or 15%, or to vehicle alone. The participants were instructed to apply the gel to the axillae once daily for 42 days. All sub- jects had Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scores of 3 or 4, on a scale of 0 – 4. HDSM-Ax is a proprie- tary, validated, patient-reported outcome for measuring axillary hyperhidrosis severity. In addition, all participants had ≥ 150mg/5min of combined axillary gravimetric sweat pro- duction (GSP). Improvement was first observed on day 8 and continued until the end of the 42-day study period. Overall, 70.2% of patients using the lowest concentration of sofpiro- nium achieved an improvement in HDSM-Ax of at least 1 point, which was significantly greater than the 54.4% of patients who achieved this improvement using the vehi- cle alone (P < .00387). Rate of improvement in the highest concentration group was 75.9% (P < .00999 vs vehicle). In addition, 59.6% of patients using the weakest concentration of sofpironium

Courtesy of the AAD

VOL. 2 • NO. 4 • 2018