Sofpironium Bromide gel 5% and 15% is safe, tolerable, and associated with a gradual and continuous improvement in primary axillary hyperhidrosis during a long-term treatment period, according to late-breaking study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
ARGYLE study results (ClinicalTrials.gov identifier NCT03627468) fortify previous safety, tolerability, and efficacy data, collected in a Phase 2b study. “As was observed with earlier clinical studies, the majority of side effects were mild or moderate in severity and transient in nature,” said Deepak Chadha, Chief Research and Development Officer at Brickell, in a press release. “Sofpironium bromide gel 5% and 15% both led to sustained improvements in sweating severity for the majority of patients through the end of 48 weeks of treatment.”
ARGYLE was a phase 3, open-label, long-term study that evaluated the safety and efficacy of sofpironium bromide gel 5% and 15% in 190 patients during 48 weeks with an additional 4-week extension period.
Study investigators found that treatment-related treatment-emergent adverse events associated with the 5% and 15% strengths were mild or moderate and transient in nature, and were experienced by 22.5% and 50.8% of patients, respectively. The most common and expected events included blurred vision, dry mouth, pruritis, pain, dermatitis, erythema, irritation, mydriasis, and urinary retention. Several of these symptoms led to treatment discontinuation, although these rates were generally low.
Overall, both treatment-emergent adverse events and discontinuations decreased over time with acclimation to the treatment. No serious adverse events were noted, and no new safety signals emerged.
In terms of efficacy, both the 5% and 15% gels demonstrated clinically meaningful improvement in axillary hyperhidrosis severity measured through a proprietary patient-reported outcome scale (Hyperhidrosis Disease Severity Measure-Axillary [HDSM-Ax]). Responders in both groups who experienced a 1- and 2-point improvement experienced “a gradual and continual improvement in sweat severity through the 48 weeks of treatment.”
According to the press release, the “safety, tolerability, and efficacy results for sofpironium bromide gel 5% and 15% in ARGYLE were consistent with prior clinical experience and no unexpected safety findings were observed.”
The phase 3 Cardigan I (and Cardigan II clinical trials (ClinicalTrials.gov identifiers NCT03836287 and NCT03948646) are currently underway, evaluating sofpironium bromide gel 15% in roughly 350 participants per study aged 9 years and older. These results, if successful, will be combined with ARGYLE and form the basis of a New Drug Application to be submitted to the FDA.
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1. Brickell Biotech reports results from U.S. phase 3 open-label, long-term safety study on chronic use of sofpironium bromide gel as a potential treatment for primary axillary hyperhidrosis. News Release. Brickell Biotech. Presented at: AAD VMX 2021; April 23-25, 2021.
2. Smith S. A multicenter, randomized, open-label, phase 3 long-term safety study (Argyle) of topically applied sofpironium bromide (SB) gel, 5% and 15%, in subjects with primary axillary hyperhidrosis. Presented at: AADVMX 2021; April 23-25, 2021. Presentation SYMS033.