Brickell’s Phase III Data Sets Up NDA Filing In Axillary Hyperhidrosis

Brickell Biotech, Inc. said on 7 October that it plans to file a new drug application by mid-2022 for sofpironium bromide gel 15% (SB gel) to treat primary axillary hyperhidrosis after the anticholinergic met the primary endpoint and all secondary endpoints in a pair of pivotal Phase III studies. On a same-day investor call, CEO Robert Brown said SB gel could offer a best-in-class treatment option for a disease that affects an estimated 15 million Americans.

In the Cardigan I and Cardigan II trials, the topical dosed once each night at bedtime met the primary endpoint of at least a two-point improvement in HDSM-Ax (Hyperhidrosis Disease...