FDA clears targeted alkali thermolysis product for hyperhidrosis treatment

Key takeaways:

• The FDA has cleared Brella, a noninvasive, targeted alkali thermolysis product that treats primary axillary hyperhidrosis.
• Brella will be available in select U.S. markets late this summer.

The FDA has approved a de novo request for Brella, a noninvasive treatment option for primary axillary hyperhidrosis that utilizes targeted alkali thermolysis technology, Candesant Biomedical announced in a press release.

“Eighty percent of consumers said they’re seeking a new treatment option for excessive underarm sweating, a condition that curtails activities, stains clothes, causes frustration and embarrassment, undermines confidence and has been inadequately treated for far too long,” Niquette Hunt, founder and CEO of Candesant, told Healio.

Using Candesant’s targeted alkali thermolysis (TAT) technology, Brella reduces excessive underarm sweating in adults with primary axillary hyperhidrosis. According to the release, this single-use, disposable, aluminum-free patch has proven to reduce excessive sweating for up to 3 to 4 months and can be easily administered in-office.

Niquette Hunt

“Brella, the first and only 3-minute SweatControl Patch, is a significant advance for the millions of people dealing with the physical, emotional, financial and aesthetic impact of axillary hyperhidrosis or excessive underarm sweating,” Hunt told Healio.

The clearance is supported by the results of SAHARA, a randomized, double-blind, sham-controlled study that was presented at the American Academy of Dermatology Annual Meeting.

SAHARA results showed that 64% of patients treated with the TAT patch achieved Hyperhidrosis Disease Severity Scale improvement compared with 44% of sham-treated patients by week 4. Gravimetric sweat production decreased by more than 50% in 60.5% of treated patients, with a mean reduction of 57.3 mg per 5 minutes in the treatment group vs. 18.2 mg per 5 minutes in the sham group (P = .0036).

By late summer, Brella will be available in select U.S. markets through the Candesant Brella Early Experience Program, which will include health care providers with practices focused on hyperhidrosis treatment. A national launch will follow this program, according to the release.

Reference:

• Pariser DM. Outcomes from the SAHARA clinical study on the TAT patch for excessive axillary sweating or primary axillary hyperhidrosis. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.