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

 
• By Joseph Haas

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.

Diagnosis - Hyperhidrosis. Medical Concept with Blurred Text, Stethoscope, Pills and Syringe on Green Background. Selective Focus. 3D Render.
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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UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

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UCB Follows Fellow European Pharmas With Major US Investment

 
• By Kevin Grogan

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