Brickell Biotech has just announced the findings from their Phase 3 study investigating the long-term efficacy and safety of sofpironium bromide gel for the treatment of primary axillary hyperhidrosis.
Hyperhidrosis is a rare condition which causes excessive sweating. The primary axillary form of the condition presents with excessive underarm sweating. It is the most common form and it is the first form of the condition where sofpironium bromide has been investigated as a potential treatment option.
Sofpironium bromide gel works by blocking acetylcholine from acting in the body. This chemical is responsible for activating the sweat glands. The gel provides action locally.
This study was called ARGYLE. It tested the gel as a once-daily therapy applied topically. Both 5% and 15% were examined. This study lasted for 48 weeks in total. All patients in the trial were 9 years old or older, and there were a total of 300 participants across 30 different trial sites in the United States.
All patients were randomized to determine their percentage and then given the treatment once daily for 48 weeks. All participants also had a follow-up appointment 4 weeks after treatment. A total of 190 patients participated for the entire 52 weeks.
This study continued to support the findings found in the Phase 2b trial. There were no severe side effects documented and at both 5% and 15%, patients experienced sustained improvements in their condition. Further, over time the number of adverse events experienced by patients decreased.
The most common adverse events included-
- Blurred vision
- Dry mouth
- Urinary Retention
Measures of hyperhidrosis disease severity, which was a patient-reported outcome, demonstrated positive outcomes at both the 5% and 15% doses. Improvement in sweating was consistent across the treatment period.
There are currently two trials in the United States investigating this therapy. They are Phase 3 trials called Cardigan 1 (NCT03836287) and Cardigan 2 (NCT03948646). Each study has about 350 participants.
Data is expected from these studies in the last quarter of this year.
Following these investigations, their data in combination with the ARGYLE data will help to form the New Drug Application.
You can read more about this study and investigative therapy here.