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Erschienen in: Drugs 18/2020

01.12.2020 | AdisInsight Report

Sofpironium Bromide: First Approval

verfasst von: Julia Paik

Erschienen in: Drugs | Ausgabe 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.
Literatur
1.
Zurück zum Zitat Shargall Y, Spratt E, Zeldin RA. Hyperhidrosis: what is it and why does it occur? Thorac Surg Clin. 2008;18(2):125–32, v. Shargall Y, Spratt E, Zeldin RA. Hyperhidrosis: what is it and why does it occur? Thorac Surg Clin. 2008;18(2):125–32, v.
2.
Zurück zum Zitat Amir M, Arish A, Weinstein Y, et al. Impairment in quality of life among patients seeking surgery for hyperhidrosis (excessive sweating): preliminary results. Isr J Psychiatry Relat Sci. 2000;37(1):25–31.PubMed Amir M, Arish A, Weinstein Y, et al. Impairment in quality of life among patients seeking surgery for hyperhidrosis (excessive sweating): preliminary results. Isr J Psychiatry Relat Sci. 2000;37(1):25–31.PubMed
3.
Zurück zum Zitat Campanati A, Penna L, Guzzo T, et al. Quality-of-life assessment in patients with hyperhidrosis before and after treatment with botulinum toxin: results of an open-label study. Clin Ther. 2003;25(1):298–308.CrossRef Campanati A, Penna L, Guzzo T, et al. Quality-of-life assessment in patients with hyperhidrosis before and after treatment with botulinum toxin: results of an open-label study. Clin Ther. 2003;25(1):298–308.CrossRef
4.
Zurück zum Zitat Solish N, Bertucci V, Dansereau A, et al. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007;33(8):908–23.PubMed Solish N, Bertucci V, Dansereau A, et al. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007;33(8):908–23.PubMed
7.
Zurück zum Zitat Brickell Biotech. Brickell Biotech provides update on Bodor Labs complaint and funding agreement with NovaQuest [media release]. 30 Oct 2019. http://brickellbio.com. Brickell Biotech. Brickell Biotech provides update on Bodor Labs complaint and funding agreement with NovaQuest [media release]. 30 Oct 2019. http://​brickellbio.​com.
8.
Zurück zum Zitat Brickell Biotech. Brickell Biotech announces settlement of dispute with Bodor Labs and entry into equity funding agreements [media release]. 18 Feb 2020. http://brickellbio.com. Brickell Biotech. Brickell Biotech announces settlement of dispute with Bodor Labs and entry into equity funding agreements [media release]. 18 Feb 2020. http://​brickellbio.​com.
9.
Zurück zum Zitat Brickell Biotech. Brickell Biotech, Inc. signs exclusive license and development agreement for BBI-4000 with Kaken Pharmaceutical Co., Ltd [media release]. 1 Apr 2015. http://brickellbio.com. Brickell Biotech. Brickell Biotech, Inc. signs exclusive license and development agreement for BBI-4000 with Kaken Pharmaceutical Co., Ltd [media release]. 1 Apr 2015. http://​brickellbio.​com.
11.
Zurück zum Zitat 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. 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.
12.
Zurück zum Zitat 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. 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.
13.
Zurück zum Zitat 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 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
14.
Zurück zum Zitat 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. 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.
15.
Zurück zum Zitat Brickell Biotech. Brickell Biotech reports first quarter 2020 financial results and provides corporate update [media release]. 13 May 2020. http://brickellbio.com. Brickell Biotech. Brickell Biotech reports first quarter 2020 financial results and provides corporate update [media release]. 13 May 2020. http://​brickellbio.​com.
16.
17.
Zurück zum Zitat 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/. 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/​.
18.
Zurück zum Zitat 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. 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.
Metadaten
Titel
Sofpironium Bromide: First Approval
verfasst von
Julia Paik
Publikationsdatum
01.12.2020
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 18/2020
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-020-01438-1

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