Brickell plans to submit new drug application to FDA for gel

BOULDER — On the heels of a recently completed phase three clinical trial, Brickell Biotech Inc. (Nasdaq: BBI) plans to submit a new drug application to the U.S. Food and Drug Administration next year for its sofpironium bromide gel, which could treat excessive underarm sweating. 

“We are excited to report the positive topline results from our pivotal Phase 3 clinical studies. These data are highly encouraging and further reinforce our belief that sofpironium bromide gel 15% has the potential to become a best-in-class treatment option for the millions of patients suffering from primary axillary hyperhidrosis (excessive underarm sweating),” Brickell CEO Robert Brown said in a prepared statement.

The phase three trial involved two studies with more than 700 participants total. Subjects applied sofpironium bromide gel or placebo to their underarms once daily at bedtime for six consecutive weeks, with a two-week post-treatment follow-up.

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The trial found that the gel was “generally well-tolerated” with adverse reactions that were “mild or moderate in severity and transient in nature,” according to a company news release.

“I feel privileged to have served as a principal investigator in the U.S. pivotal Phase 3 program,” dermatologist Dr. Stacy Smith said in the release. “There is a real need for new and improved hyperhidrosis treatment options, and the results from these pivotal Phase 3 studies further support the potential for sofpironium bromide gel 15% to become a first-line therapy of choice for patients with primary axillary hyperhidrosis.”