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Published in: Drugs 18/2020

01-12-2020 | Hyperhidrosis | AdisInsight Report

Sofpironium Bromide: First Approval

Author: Julia Paik

Published in: Drugs | Issue 18/2020

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Abstract

Sofpironium bromide (ECCLOCK® in Japan) gel is a topical anticholinergic agent developed by Bodor Laboratories and licenced to Brickell Biotech for the treatment of hyperhidrosis. The drug is designed to reduce sweating by inhibiting M3 muscarinic receptors in eccrine glands at the application site. In September 2020, sofpironium bromide gel 5% received its first approval in Japan for the treatment of primary axillary hyperhidrosis (PAH). Clinical studies are currently ongoing in the USA to assess the safety and efficacy of sofpironium bromide gel 15% in PAH. This article summarizes the milestones in the development of sofpironium bromide gel leading to this first approval for the treatment of PAH.
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Yokozeki H, Fujimoto T, Yorozuya T, et al. A phase 3, randomized, double-blinded, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide gel, 5% in Japanese patients with primary axillary hyperhidrosis [abstract no. S027]. In: American Academy of Dermatology, Virtual Meeting Experience. 2020.
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Brickell Biotech. Brickell Biotech announces positive phase 3 pivotal study results for sofpironium bromide in Japan released by development partner, Kaken Pharmaceutical [media release]. 15 Jun 2020. http://​brickellbio.​com.
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Kirsch B, Smith S, Cohen J, et al. Efficacy and safety of topical sofpironium bromide gel for the treatment of axillary hyperhidrosis: a phase II, randomized, controlled, double-blinded trial. J Am Acad Dermatol. 2020;82(6):1321–7.CrossRef
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Brickell Biotech. BBI-4000 (sofpironium bromide) demonstrates promising potential as a safe and effective first-line treatment for excessive underarm sweating [media release]. 7 Mar 2016. http://​brickellbio.​com.
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Brickell Biotech. Brickell Biotech announces initiation of US phase 3 program evaluating sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis [media release]. 6 Oct 2020. https://​brickellbio.​com/​.
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Brickell Biotech. Brickell Biotech reports fourth quarter and full year 2019 financial results and provides corporate update [media release]. 18 Mar 2020. http://​brickellbio.​com.
Metadata
Title
Sofpironium Bromide: First Approval
Author
Julia Paik
Publication date
01-12-2020
Publisher
Springer International Publishing
Keyword
Hyperhidrosis
Published in
Drugs / Issue 18/2020
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-020-01438-1

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