Brickell plans to re-submit drug to FDA for gel

In the wake of a recently completed phase three clinical trial, Brickell Biotech Inc. (Nasdaq: BBI) plans to submit a new drug application to the United States Food and Drug Administration for its bromide gel next year. sofpironium, which may treat excessive underarm sweating.

“We are delighted to report the first positive results from our pivotal Phase 3 clinical studies. These data are very encouraging and further strengthen our belief that sofpironium bromide 15% gel has the potential to become a treatment option for first order for the millions of patients with primary axillary hyperhidrosis (excessive underarm sweating), ”said Robert Brown, CEO of Brickell, in a statement.

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

The trial found that the gel was “generally well tolerated” with side effects “of mild or moderate intensity and transient in nature,” according to a press release from the company.

“I feel privileged to have been a Principal Investigator in the US 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 of these pivotal Phase 3 studies further support the potential of 15% sofpironium bromide gel to become a first-line treatment for choice for patients with primary axillary hyperhidrosis. “

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