Sofdra FDA Approval History

Last updated by Judith Stewart, BPharm on June 23, 2024.

FDA Approved: Yes (First approved June 18, 2024)
Brand name: Sofdra
Generic name: sofpironium
Dosage form: Topical Gel
Company: Botanix Pharmaceuticals Ltd.
Treatment for: Hyperhidrosis

Sofdra (sofpironium) is a topical anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older

• Primary axillary hyperhidrosis is a condition characterised by abnormally increased underarm sweating, beyond that required to regulate body temperature.
• Sofdra contains sofpironium which is an anticholinergic/antimuscarinic drug that works to block sweating by inhibiting M3 muscarinic receptors in the eccrine sweat glands.
• The FDA approval of Sofdra was supported by results from the two pivotal Phase 3 CARDIGAN studies evaluating the efficacy and safety of Sofdra versus vehicle. Sofdra successfully met all primary and secondary endpoints with clinically and statistically meaningful changes from baseline in Gravimetric Sweat Production (GSP) and the Hyperhidrosis Disease Severity Measure-Axillary, 7-item (HDSM-AX7) score.
• Sofdra gel is administered topically to each underarm area once a day at bedtime.
• Warnings and precautions associated with Sofdra include caution in patients with urinary retention, impaired control of body temperature in hot environments, and transient blurred vision that may affect ability to operate a motor vehicle or other machinery.
• Common adverse reactions (incidence ≥2%) include dry mouth, vision blurred, application site pain, application site erythema, mydriasis, application site dermatitis, application site pruritus, urinary retention, and application site irritation.

Development timeline for Sofdra

Further information

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