Tuesday, July 16, 2024

Primary Axillary Hyperhidrosis: FDA Approves New Treatment

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Primary axillary hyperhidrosis treatment has advanced with the Food and Drug Administration’s (FDA) approval of sofpironium topical gel, 12.45%, for adults and children aged 9 years and older. Developed by Botanix Pharmaceuticals, this product will be marketed under the brand name Sofdra.

The FDA’s approval was based on data from two phase 3 clinical trials, which collectively enrolled 710 patients with primary axillary hyperhidrosis. The trials demonstrated that patients treated with sofpironium topical gel, 12.45%, experienced clinically and statistically significant improvements in both the Gravimetric Sweat Production and the Hyperhidrosis Disease Severity Measure-Axillary seven-item score. These findings underscore the efficacy of Sofdra in managing excessive underarm sweating.

Primary Axillary Hyperhidrosis: Phase 3 Studies Confirm Effectiveness of Sofpironium Topical Gel

The phase 3 studies provided compelling evidence for the effectiveness of sofpironium topical gel. Participants showed notable reductions in sweat production and severity of symptoms, marking a significant advancement for those affected by primary axillary hyperhidrosis. This condition, characterized by excessive underarm sweating, can severely impact quality of life, making the availability of effective treatments crucial.

Botanix Pharmaceuticals plans to enable qualified patients to gain early access to Sofdra in the third quarter of 2024, with commercial sales expected to begin in the fourth quarter of 2024. This timeline reflects the company’s commitment to providing timely access to this new treatment option for those suffering from primary axillary hyperhidrosis.

Sofpironium topical gel is a topical anticholinergic agent. Anticholinergics work by blocking the action of acetylcholine, a neurotransmitter involved in stimulating sweat production. By applying this mechanism topically, Sofdra can specifically target the sweat glands in the underarm area, reducing excessive sweating without affecting the body’s overall function.

Primary Axillary Hyperhidrosis

Primary Axillary Hyperhidrosis: Approval of Sofpironium Topical Gel Significantly Enhances Patient Quality of Life

The approval of Sofpironium topical gel represents a significant development for individuals with primary axillary hyperhidrosis. This condition can lead to social embarrassment, emotional distress, and physical discomfort. Effective management can greatly enhance the quality of life for these patients, allowing them to engage more confidently in daily activities.

Experts in dermatology and hyperhidrosis have welcomed the FDA’s decision. The clinical data supporting Sofdra’s approval indicates its potential to become a cornerstone in the management of primary axillary hyperhidrosis. Dermatologists highlight that this new treatment offers a non-invasive, easy-to-use option that can be seamlessly integrated into patients’ daily routines.

Looking ahead, Botanix Pharmaceuticals aims to expand the availability of Sofpironium topical gel beyond the United States. The company is preparing to submit applications for regulatory approval in other regions, ensuring that patients worldwide can benefit from this innovative treatment. Additionally, ongoing research may explore further applications of anticholinergic therapy for other forms of hyperhidrosis.

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The FDA’s approval of sofpironium topical gel, 12.45%, for primary axillary hyperhidrosis marks a milestone in the treatment of this challenging condition. With its demonstrated efficacy and targeted mechanism of action, Sofdra offers a promising new option for patients struggling with excessive underarm sweating. Botanix Pharmaceuticals’ efforts to expedite patient access and their plans for future expansion underscore the potential impact of this treatment on improving patient lives globally.


Resource: Botanix Pharmaceuticals, June 20, 2024

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