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The Food and Drug Administration (FDA) has granted approval for a new treatment option for individuals suffering from primary axillary hyperhidrosis. Sofpironium topical gel, 12.45%, developed by Botanix Pharmaceuticals, has been authorized for use in both adults and children aged 9 years and older. The treatment will be marketed under the brand name Sofdra.
Primary axillary hyperhidrosis is a condition characterized by excessive underarm sweating, which can significantly impact the quality of life. The approval of Sofdra is based on the promising results from two phase 3 clinical trials involving 710 patients. These trials demonstrated that sofpironium topical gel, 12.45%, led to “clinically and statistically meaningful changes” in key measures of sweat production and disease severity. Specifically, patients experienced notable improvements in Gravimetric Sweat Production and the Hyperhidrosis Disease Severity Measure-Axillary seven-item score.
“We are thrilled to offer a new, effective treatment option for those affected by primary axillary hyperhidrosis,” said a spokesperson from Botanix Pharmaceuticals. “The results from our phase 3 studies underscore the potential of sofpironium gel to provide meaningful relief for patients.”
Botanix Pharmaceuticals plans to make Sofdra available to qualified patients as early as the third quarter of 2024, with broader commercial availability anticipated in the fourth quarter of the same year. This early access program aims to provide relief to those who need it most, ahead of the full market release.
Primary axillary hyperhidrosis affects millions of people worldwide, often leading to significant physical and emotional distress. Current treatment options include antiperspirants, oral medications, and invasive procedures, each with varying degrees of effectiveness and potential side effects. Sofpironium gel offers a promising new topical solution that could simplify and improve the management of this condition.
The approval of Sofdra marks a significant advancement in the treatment of hyperhidrosis, providing hope for better management and improved quality of life for those affected. As the launch date approaches, patients and healthcare providers alike are looking forward to incorporating this new treatment into their care plans.
