Sofpironium Bromide: First Approval
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ADISINSIGHT REPORT
Sofpironium Bromide: First Approval Julia Paik1 Published online: 24 November 2020 © Springer Nature Switzerland AG 2020
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.
Sofpironium bromide ( ECCLOCK® gel): Key points A topical anticholinergic agent is being developed by Bodor Laboratories and licenced to Brickell Biotech for the treatment of hyperhidrosis Received its first approval on 25 September 2020 in Japan Approved for the treatment of PAH
1 Introduction Hyperhidrosis is characterized by excessive sweating beyond the physiologically required amount [1] and may significantly impact the affected individual’s quality of life and mental and emotional wellbeing [2, 3]. Primary Enhanced material for this AdisInsight Report can be found at https://doi.org/10.6084/m9.figshare.13185041. This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through preclinical and clinical studies to market launch and beyond. * Julia Paik [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
hyperhidrosis is idiopathic and may occur as a result of aberrant sympathetic and parasympathetic nervous activity overstimulating the sweat glands [4], which include eccrine glands (distributed all over the body) and apocrine glands (localized in the axillae and urogenital region); these are regulated via cholinergic and adrenergic neurotransmission, respectively [1]. Apoeccrine sweat glands, which are regulated largely through cholinergic activity, are also present in adult axillae and may have a significant role in axillary hyperhidrosis [1]. Topical aluminium chloride antiperspirants are typically the first-line treatment option for axillary hyperhidrosis but may lead to skin irritation, particularly with more potent doses [4]. Later-line options for patients not responding to topical aluminium chloride include botulinum toxin A injections and surgery (local surgery or endoscopic thoracic sympathectomy) [4]. Sofpironium bromide gel is a topical anticholinergic agent developed by Bodor Laboratories and licenced to Brickell Biotech for the treatment of hyperhidrosis. On 25 September 2020, sofpironium bromide gel 5% received its first approval in Japan as E CCLOCK® gel 5% for the treatment of primar
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