Sofdra™ Receives FDA Approval for Primary Axillary Hyperhidrosis

Botanix Pharmaceuticals Ltd (ASX:BOT) is pleased to announce the U.S. Food and Drug Administration (FDA) approval of Sofdra™ (sofpironium) topical gel, 12.45%. This marks a significant milestone for both Botanix and patients struggling with primary axillary hyperhidrosis, a condition characterized by excessive underarm sweating.

Sofdra: A Novel Therapeutic Option

Sofdra is the first entirely new chemical entity to receive FDA approval specifically for primary axillary hyperhidrosis. Unlike previously available treatments, Sofdra offers a topical solution for adults and children nine years and older. This innovative gel provides a new avenue for effective management of this often-debilitating condition.

Addressing a Significant Unmet Need

Primary axillary hyperhidrosis affects an estimated 10 million people in the US alone. The excessive sweating associated with this condition can have a profound impact on a patient’s quality of life. From disrupting daily activities to causing social anxiety and embarrassment, primary axillary hyperhidrosis can significantly affect emotional well-being. With limited treatment options available until now, the FDA approval of Sofdra represents a major step forward in addressing this unmet medical need.

Clinical Studies Pave the Way for Approval

The FDA based its approval on the robust data collected from the two pivotal Phase 3 CARDIGAN trials. These studies enrolled over 700 patients with primary axillary hyperhidrosis and evaluated the efficacy and safety of Sofdra compared to a placebo. The studies demonstrated that Sofdra met all primary and secondary endpoints, achieving statistically significant reductions in sweat production and improvements in patient-reported outcomes.

Making Sofdra Accessible to Patients

Botanix is committed to ensuring that patients can access this new treatment option. The company plans to launch a patient experience program in Q3 2024. This program will allow select patients to gain early access to Sofdra and receive guidance through the telemedicine and insurance reimbursement process. A broader commercial launch is expected to follow in early Q4 2024, with Botanix anticipating its first revenue from Sofdra sales during this timeframe.

Important Safety Information to Consider

It is important to remember that Sofdra is a prescription medication intended for topical use on the underarms only. Patients should consult with a healthcare professional to determine if Sofdra is appropriate for their individual needs and medical history. Certain medical conditions may preclude the use of Sofdra. Common side effects associated with Sofdra include dry mouth, blurred vision, and irritation in the underarm area.

For more detailed information on Sofdra, including full prescribing information, please visit the Botanix Pharmaceuticals website.