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

 
• By Joseph Haas
  
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Meeting all primary and secondary endpoints in a pair of pivotal trials, Brickell says sofpironium bromide gel will be ready for FDA filing in mid-2022. The topical is already approved in Japan as Ecclock.

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Brickell hopes to improve the standard of care for 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...

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