Sofpironium Topical Gel (Sofdra)
August 30, 2024
By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco. Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
The U.S. Food and Drug Administration has approved a second topical anticholinergic product for the treatment of hyperhidrosis, after a single-use cloth pre-moistened with glycopyrronium (Qbrexza) in 2018. Sofpironium bromide is an inhibitor of acetylcholine receptors resulting in reduced rate of sweating. It was first approved and marketed in Japan in 2020. It will be distributed in the United States by Botanix SB Inc. as Sofdra.
Indications
Sofpironium topical gel is indicated for the treatment of primary axillary hyperhidrosis in patients 9 years of age and older.1
Dosage
The recommended dose is application of a single pump actuation to clean, dry skin of the underarm once at bedtime.1 A second, separate actuation is applied to the second underarm.
Sofpironium is available as a topical gel (12.45%) in 50 mL bottle. Each full pump actuation delivers 0.67 mL of gel providing 72 mg of sofpironium.
Potential Advantages
Sofpironium topical gel provides another treatment option for primary axillary hyperhidrosis.
Potential Disadvantages
Sofpironium is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic action of sofpironium, such as glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, myasthenia gravis, and Sjögren’s syndrome.1
Use with caution in individuals with a history of urinary retention. Use should be avoided if not sweating in the presence of high ambient temperature. The most common adverse reactions (> 5%) include dry mouth (14%), blurred vision (9%), mydriasis (7%), and application site reactions (pain, erythema, pruritis) (5% to 8%).1
Comments
The efficacy and safety of sofpironium was evaluated in two randomized, vehicle-controlled trials in subjects with primary axillary hyperhidrosis (Cardigan 1 and Cardigan 2).1
Eligibility criteria were age ≥ 9 years of age, symptoms of axillary hyperhidrosis for at least six months, production of at least 50 mg of sweat in each axilla with a combined total of at least 150 mg over a five-minute period and a Hyperhidrosis Disease Severity Measure-Axillary, seven-item scale score (HDSM-Ax-7) of ≥ 3 (i.e., hyperhidrosis is barely tolerable or intolerable).
Subjects were randomized to sofpironium (n = 172 and 178, respectively) or the vehicle (n = 177 and 169, respectively).
The co-primary endpoints were the proportion of subjects having at least a two-point improvement in HDSM-Ax-7 and change in gravimetric sweat production (GSP) from baseline to day 43. Forty-nine percent achieved a ≥ 2 point improvement vs. 29% in Cardigan 1 and 64% vs. 48%, respectively, for Cardigan 2. There was a 60% reduction of GSP (mg/five minutes) in the sofpironium group vs. reduction of 44% for the vehicle group in Cardigan 1 and -69% and -58%, respectively, for Cardigan 2.
Clinical Implications
Hyperhidrosis is a chronic disorder of excess sweat production that may significantly affect one’s quality of life. These individuals episodically sweat four or five times more than is considered “normal” or expected to control body temperature or as a reaction to stress, activity, or excitement.2,3 Axillary hyperhidrosis affects slightly more than 3% of the U.S. population.4
Initial pharmacological treatment generally is aluminum-based antiperspirants.5 Other treatments for more severe cases include topical glycopyrronium cloth; botulinum toxin injections (Botox); and oral anticholinergics, such as glycopyrrolate, and beta-blockers (for episodic and event-driven hyperhidrosis).
Sofpironium offers a new topical treatment for axillary hyperhidrosis. It is a good candidate treatment for telemedicine, potentially expanding its reach to patients who may be self-conscious about talking to their healthcare providers directly — only about one-third of individuals seek medical treatment.
The cost of sofpironium is not available at this time (estimated availability Q4 2024) but is expected to be on par with topical glycopyrronium cloth.
References
- U.S. Food and Drug Administration. Sofdra prescribing information. Botanix SB Inc. June 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf
- Nawrocki S, Cha J. The etiology, diagnosis, and management of hyperhidrosis: A comprehensive review: Therapeutic options. J Am Acad Dermatol 2019;81:669-680.
- International Hyperhidrosis Society. Defining hyperhidrosis. https://sweathelp.org/home/defining-hyperhidrosis.html
- Sammons JE, Khachemoune A. Axillary hyperhidrosis: A focused review. J Dermatolog Treat 2017;28:582-590.
- International Hyperhidrosis Society. Hyperhidrosis treatment overview. https://www.sweathelp.org/hyperhidrosis-treatments/treatment-overview.html
The U.S. Food and Drug Administration has approved a second topical anticholinergic product for the treatment of hyperhidrosis.
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