From April 23 to 25, 2021, the American Academy of Dermatology (AAD) held their 2021 Virtual Meeting Experience (AAD VMX 2021). During the meeting, a variety of dermatology stakeholders discussed new research and advances within the field. One of the presentations centered around sofpironium bromide gel 5% and 15%, treatment options for patients with primary axillary hyperhidrosis. According to Dermatology Advisor, data from the Phase 3 ARGYLE clinical trial showed the treatment’s safety, efficacy, and tolerability. Interested in seeing some of the study data? Click here.

Sofpironium Bromide

During the ARGYLE clinical trial, researchers evaluated the safety, efficacy, and tolerability of two sofpironium bromide gel doses. Developed by Brickell Biotech, Inc. (“Brickell“):

Sofpironium bromide is a proprietary new chemical entity that we are currently developing in the U.S. as a potential best-in-class, self-administered, once-daily, topical therapy for the treatment of primary axillary (underarm) hyperhidrosis. [The gel] was designed as a structural analog of a well-known potent anticholinergic, glycopyrrolate, to achieve its therapeutic effect at the application site (skin) similar to glycopyrrolate.

Altogether, 190 patients enrolled in the ARGYLE study. Over a 48-week period (and a 4-week extension), patients received either sofpironium bromide gel 5% or 15%. Researchers determined that:

• Sofpironium bromide gel was relatively safe and well-tolerated. While some mild-to-moderate adverse reactions did occur, only a few patients discontinued treatment. Common side effects included:
  • Blurry vision
  • Pruritus (intense itching)
  • Dilated pupils
  • Urinary retention
  • Skin pain, redness, or irritation
  • Dry mouth
• Using this treatment helped reduce symptoms associated with primary axillary hyperhidrosis. While using sofpironium bromide gel, patients experienced up to 2 points of improvement in the Hyperhidrosis Disease Severity Measure-Axillary scale.
• Treatment results were sustained over the entire 48-week period.

Currently, researchers are also evaluating sofpironium bromide gel 15% in the Phase 3 Cardigan I and Cardigan II clinical trials. Altogether, 350 patients enrolled in each study. If the data supports current findings, Brickell will use these findings, as well as data from the ARGYLE trial, to develop a New Drug Application (NDA).

Primary Hyperhidrosis

Caused by oversensitive nerves and sweat glands, primary hyperhidrosis is a rare condition characterized by excessive sweatiness. Overall, the sweat can be generalized – occurring all over the body – or localized. In localized cases, excess sweat is usually found on the feet or palms, armpits, breasts, or groin. For example, the sofpironium bromide gel is being developed for primary axillary hyperhidrosis, occurring in the armpits. Primary hyperhidrosis means that the condition occurs on its own. This is not to be confused with secondary hyperhidrosis, which occurs as a symptom of another condition. Typically, symptoms associated with primary hyperhidrosis appear during childhood or puberty and last throughout life. Patients often experience increased sweating in relation to stimuli such as caffeine or nicotine, stress, or pain. Symptoms include:

• Excessive sweating
• Persistent blushing
• Pink or bluish-white skin discoloration (in affected areas)
• Scaling or cracked skin
• Somewhat frequent skin infections

Learn more about primary hyperhidrosis.