Clinical dermatology company, Botanix Pharmaceuticals Ltd. announced the U.S. Food and Drug Administration (FDA) has approved Sofdra™ (sofpironium) gel, 12.45%, a prescription medicine used to treat primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years and
older.
- Hyperhidrosis is a condition characterized by abnormally increased sweating, beyond that required
to regulate body temperature. The disproportionate sweat production that characterizes
hyperhidrosis, results in a disabling medical condition with profound effects on the patient’s quality
of life. - Sofdra is the first and only new chemical entity approved by the FDA to treat primary axillary
hyperhidrosis and presents a novel safe and effective solution for patients who have lacked
treatment options for this socially challenging medical condition. - Hyperhidrosis is the third largest dermatology condition (after acne and atopic dermatitis), with
approximately 10 million patients in the US with primary axillary hyperhidrosis.
