FDA approves Sofdra gel for primary axillary hyperhidrosis

Key takeaways:

• Sofdra (sofpironium) gel 12.45% is the first and only chemical entity for primary axillary hyperhidrosis.
• The approval was supported by two phase 3 trials.

The FDA has approved Sofdra gel 12.45% for the treatment of primary axillary hyperhidrosis in adults and children aged 9 years and older, Botanix Pharmaceuticals announced in a press release.

Characterized by excessive underarm sweating, hyperhidrosis can be a socially, mentally and sometimes physically debilitating condition. As the third largest dermatology condition in U.S., hyperhidrosis can not only affect a patient’s ability to work productively and participate in daily routine activities, but it can also greatly impact patients’ relationships and mental states, according to the press release.

This patient population has historically had limited treatment options, making Sofdra (sofpironium) gel 12.45% a safe, effective and welcomed addition to hyperhidrosis’ armamentarium.

“We are very excited to provide a new option for the 10 million patients with primary axillary hyperhidrosis in the U.S.,” Vince Ippolito, executive chairman of Botanix, said in the release. “As the first and only new chemical entity, Sofdra represents a new therapeutic approach for dermatologists to treat patients with this disabling medical condition.”

The approval was supported by results from two pivotal phase 3 trials that fall under the CARDIGAN studies. In these studies, Sofdra’s efficacy and safety were evaluated among 701 patients with primary axillary hyperhidrosis.

Results showed that Sofdra successfully met all primary and secondary endpoints, with many patients achieving statistically meaningful changes from baseline in both gravimetric sweat production and Hyperhidrosis Disease Severity Measure-Axillary seven-item scores.

The company is planning to launch an early patient experience program to enable highly qualified patients to gain early access to Sofdra, as well as be guided through the telemedicine and payer reimbursement process, in quarter three of this year.

After the FDA approval, Botanix further announced it has received commitments that total $70 million via institutional placement to aid the launch of Sofdra in the U.S. The broader launch of the drug is expected in quarter four of this year.

Reference:

• Botanix secures commitments for $70 million via institutional placement to fund launch of Sofdra. https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02819707-6A1212486. Published June 21, 2024. Accessed June 21, 2024.