Brickell Plans to Submit New Drug Application to FDA for gel
Brickell Biotech will request the FDA in mid-2022 to approve its gel for excessive underarm sweating after decreasing sweat production and disease severity in two pivotal trials.
The gel achieved statistical significance in lessening the severity of hyperhidrosis and the amount of sweat produced and enhanced secondary outcomes in the two-phase three trials conducted in the U.S, called Cardigan 1 and 2, as said by Brickell.
A total of 701 patients were either given the gel or placebo daily for six weeks across the two late-stage trials. The gel, known as sofpironium bromide gel, 15%, was given ...
