What is it prescribed for?
Sofdra, approved on June 18, 2024, is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older.
What is the name of the drug and what does it do?
Sofdra (pronounced SOF-drah), (generic name: sofpironium bromide), is a medication used to treat primary axillary hyperhidrosis.
This condition is characterized by excessive sweating in the underarm area, which can significantly impact the quality of life for those affected.
How does it work?
Sofdra is an anticholinergic agent. It works by blocking the action of acetylcholine, a neurotransmitter that stimulates sweat glands.
By inhibiting acetylcholine, Sofdra reduces the amount of sweat produced in the underarm area, helping to manage symptoms of hyperhidrosis effectively.
What did the research discover?
Clinical trials, including the CARDIGAN 1 and CARDIGAN 2 studies, demonstrated that Sofdra significantly reduces underarm sweating.
In these trials, a higher percentage of patients using Sofdra showed a substantial reduction in sweat production compared to those using a placebo.
Patients also reported improved quality of life due to reduced sweating.
What are some of the side effects?
- Dry mouth
- Blurred vision
- Application site pain
- Application site erythema (redness)
- Mydriasis (dilated pupils)
- Application site dermatitis
- Application site pruritus (itching)
- Urinary retention
- Application site irritation
What are the dosage recommendations and how is it prescribed?
Sofdra is applied topically as a gel. The recommended dosage is one pump of Sofdra per underarm once daily at bedtime.
Patients should apply the gel to clean, dry skin and allow it to dry completely before dressing. It is important not to wash the underarms or engage in activities that cause sweating for at least 8 hours after application.
Patients should follow their healthcare provider’s instructions and avoid applying the gel to broken skin or using occlusive dressings.
Source:
Botanix SB Inc. Sofdra (sofpironium bromide) topical gel. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217347s000lbl.pdf
