A phase III, 52‐week, open‐label study to evaluate the safety and efficacy of 5% sofpironium bromide (BBI‐4000) gel in Japanese patients with primary axillary hyperhidrosis

Fujimoto, Tomoko; Abe, Yoichiro; Igarashi, Masaru; Ishikoh, Akiko; Omi, Tokuya; Kanda, Hiroki; Kuwabara, Hiroto; Kinoshita, Miwako; Nakasu, Ichiro; Hattori, Naoko; Horiuchi, Yuki; Maruyama, Ryuji; Mizutani, Haruko; Murakami, Yoshiyuki; Watanabe, Chiharu; Kume, Akihiro; Hanafusa, Takaaki; Hamaguchi, Masamitsu; Yoshioka, Akira; Egami, Yuriko; Matsuo, Keizo; Matsuda, Tomoko; Akamatsu, Motoki; Yorozuya, Toshiyuki; Takayama, Shinichi; Yokozeki, Hiroo

doi:10.1111/1346-8138.15927

Cited by 14 publications

(15 citation statements)

References 14 publications

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“…No serious adverse events (AE) were reported in the sofpironium group. In addition, a 52‐week, open‐label study demonstrated the long‐term efficacy and safety of sofpironium 7 …”

Section: Introductionmentioning

confidence: 99%

“…In addition, a 52week, open-label study demonstrated the long-term efficacy and safety of sofpironium. 7 Although the previous 6-week phase III study indicated the efficacy of sofpironium at 2 weeks after the initiation of sofpironium treatment, 6 to the best of our knowledge, no study has assessed its efficacy in a shorter period. Therefore, to assess the earlier effectiveness of sofpironium within the 2-week treatment from day 1 to 14, we conducted a 2-week prospective observational study of sofpironium in Japanese patients with primary axillary hyperhidrosis.…”

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confidence: 99%

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Two‐week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis

Fujimoto¹,

Okatsu

Miyama

2022

The Journal of Dermatology

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In 2020, 5% sofpironium bromide (ECCLOCK®) gel (hereinafter referred to as sofpironium) was approved in Japan for the topical treatment of primary axillary hyperhidrosis. A phase III study of sofpironium demonstrated the efficacy and safety of sofpironium; however, no study has assessed its early efficacy at <6 weeks after starting treatment. Therefore, to assess the earlier effectiveness of sofpironium, we conducted a 2‐week, single‐center, exploratory, prospective, observational study in Japanese patients with primary axillary hyperhidrosis. Patients aged ≥20 years and satisfying with a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 at baseline were eligible for the study. The primary endpoint for the effectiveness was change in the proportion of patients with a HDSS score of 1, 2, 3, or 4 during the 2‐week study period. In 80 patients included in the full analysis set (FAS), there were more women than men (93.8% vs. 6.3%), and the mean age (±standard deviation [SD]) was 33.3 ± 9.4 years. In the FAS, the proportion of patients with a HDSS score of 1 or 2 was 55.0% on day 7, and statistically significant changes were observed after day 3 compared to baseline (p < 0.05). Mean HDSS scores (±SD) were significantly decreased from baseline value of 3.5 ± 0.5 to 2.4 ± 0.9 on day 7 (p < 0.001). The median period for sofpironium treatment to achieve a HDSS score of 1 or 2 for a continuous 2 days was 6 days (95% confidence interval, 4–8). Safety was evaluated in 92 patients in the safety analysis set, and no adverse events were reported during the study period of 2 weeks. These results suggest that after 1‐week treatment with sofpironium for patients with a HDSS score of 3 or 4, approximately 50% of the patients can achieve a HDSS score of 1 or 2, which is a clinically significant improvement for the patients.

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“…No serious adverse events (AE) were reported in the sofpironium group. In addition, a 52‐week, open‐label study demonstrated the long‐term efficacy and safety of sofpironium 7 …”

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

Two‐week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis

Fujimoto¹,

Okatsu

Miyama

2022

The Journal of Dermatology

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“…[ 9 ] In particular, CNS-related adverse effects [ 36 ] Minimal None A safety analysis showed no phototoxic, genotoxic, or carcinogenic effect [ 9 ] Oxybutynin Tertiary amine structure provides ability to cross the blood–brain barrier given its lipophilic nature [ 34 ] Moderate Neurotoxicity (dementia should be considered) None Sofpironium bromide Similar in chemical structure to glycopyrronium bromide. It has a high binding affinity for the M3 cholinergic receptor at the local site of administration, but is hydrolyzed at the ester linkage to less active metabolites upon entry into blood [ 31 ] Minimal Unknown Phase II and III studies completed, currently approved in Japan Umeclidinium (UMEC) Long-acting muscarinic antagonist with minimal ability to cross the blood–brain barrier Minimal Unknown Limited studies, one phase II and III study …”

Section: Resultsmentioning

confidence: 99%

Hyperhidrosis: A Review of Recent Advances in Treatment with Topical Anticholinergics

Wong

Adlam

Potts

et al. 2022

Dermatol Ther (Heidelb)

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Background Topical anticholinergics have been reported to be effective in managing hyperhidrosis (HH) given the recent approval of glycopyrronium tosylate. Objective This review aimed to examine the effectiveness of emerging topical anticholinergic treatments for HH and their associated adverse effects in comparison to current treatment options. Methods We conducted a search within the PubMed and Embase databases for current and emerging topical anticholinergic treatments for primary HH. Results The topical anticholinergics that have been recently investigated for use in HH include glycopyrrolate, oxybutynin, sofpironium bromide, and umeclidinium. The only agent currently FDA approved is glycopyrrolate. Conclusion Knowledge of topical anticholinergic treatment options is important for patient care when managing HH. This review shows that while available safety data thus far are limited, emerging topical anticholinergics pose minimal known human risks.

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Section: Dermatologic Drugsmentioning

confidence: 99%

“…Sofpironium bromide is an anticholinergic agent that is administered topically as a gel (5%) and was approved for the treatment of primary axillary hyperhidrosis (PAH) by inhibiting M3 muscarinic receptors. 115 Sofpironium bromide exhibits structural similarity to the previously approved muscarinic receptor antagonist glycopyrronium bromide, differing only in the exocyclic alkylammonium substitution. Interestingly, glycopyrronium bromide was previously approved by the USFDA to treat a variety of ailments including excessive underarm sweating, COPD, and Meńiere's disease (vertigo caused by abnormal inner ear function).…”

Section: Clascoterone (Winlevi)mentioning

confidence: 99%

Synthetic Approaches to the New Drugs Approved During 2020

et al. 2022

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New drugs introduced to the market are privileged structures that have affinities for biological targets implicated in human diseases and conditions. These new chemical entities (NCEs), particularly small molecules and antibody–drug conjugates (ADCs), provide insight into molecular recognition and simultaneously function as leads for the design of future medicines. This Review is part of a continuing series presenting the most likely process-scale synthetic approaches to 44 new chemical entities approved for the first time anywhere in the world during 2020.

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A phase III, 52‐week, open‐label study to evaluate the safety and efficacy of 5% sofpironium bromide (BBI‐4000) gel in Japanese patients with primary axillary hyperhidrosis

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 14 publications

References 14 publications

Two‐week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis

Two‐week prospective observational study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis

Hyperhidrosis: A Review of Recent Advances in Treatment with Topical Anticholinergics

Synthetic Approaches to the New Drugs Approved During 2020

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