Drug updated on 12/11/2024
| Dosage Form | Gel (topical; 12.45%) |
| Drug Class | Anticholinergics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
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Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Sofpironium bromide gel at 5%, 10%, and 15% dosages led to significant improvements in axillary hyperhidrosis severity, with 70%, 79%, and 76% of participants, respectively, achieving ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (Hyperhidrosis Disease Severity Measure (HDSM)-Ax) score, compared to 54% for the placebo group.
- Least-square mean reductions in HDSM-Ax score were -2.02 (0.14) for the 5% dosage, -2.09 (0.14) for the 10% dosage, and -2.10 (0.14) for the 15% dosage, compared to -1.30 (0.14) for placebo. All comparisons to placebo were statistically significant (P ≤ .0001).
- Most treatment-related adverse events associated with sofpironium bromide were described as mild or moderate.
- No specific adverse events or their frequencies were detailed in the study.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sofdra (sofpironium) Prescribing Information. | 2024 | Botanix SB Inc., Wayne, PA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: A phase II, randomized, controlled, double-blinded trial | 227Subjects F: 99% M: 1% | 2020 | Journal of the American Academy of Dermatology |
Sex Distribution:
F:99%
M:1%
227Subjects
Year:
2020
Source:Journal of the American Academy of Dermatology