A phase 3, multicenter, randomized, double‐blind, vehicle‐controlled, parallel‐group study of 5% sofpironium bromide (BBI‐4000) gel in Japanese patients with primary axillary hyperhidrosis

Abstract

A phase 3 study was conducted to verify the efficacy and safety of 5% sofpironium bromide (BBI‐4000) gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidrosis. The primary efficacy end‐point was the proportion of patients who satisfied both criteria of a Hyperhidrosis Disease Severity Score (HDSS) of 1 or 2 at the end of 6‐week treatment and a 50% or more reduction in total gravimetric weight of sweat at the end of treatment relative to baseline. A total of 281 patients were randomized to receive 5% sofpironium (141 patients) or vehicle (140 patients), and all patients were included in the full analysis set (FAS). In the FAS, 70.1% of patients were female, and the median age was 35.0 years. The proportion of patients who achieved the primary efficacy end‐point was 53.9% in the sofpironium group and 36.4% in the vehicle group, with a statistically significant difference of 17.5% (95% confidence interval, 6.02–28.93) between these two groups (P = 0.003). The incidence of adverse events was 44.0% in the sofpironium group and 30.7% in the vehicle group, and the incidence of adverse drug reactions was 16.3% in the sofpironium group and 5.0% in the vehicle group. Reported adverse events were generally mild or moderate in severity. In the sofpironium group, common events (incidence, ≥5%) were nasopharyngitis (14.2%) and dermatitis/erythema at the application site (8.5%/5.7%), with no serious adverse events reported. This study demonstrated the efficacy and safety of 5% sofpironium.

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

“…In the confirmatory study, the proportion of patients with a HDSS of 1 or 2 at the end of 6-week treatment and a 50% or more reduction in total gravimetric weight of sweat from baseline to the end of treatment, which was the primary efficacy end-point, was 53.9% (76/141 patients) in the sofpironium group. 10 The proportion of patients who achieved this efficacy end-point at week 52 in the long-term study was similar to that in the confirmatory study. In addition, all the other efficacy endpoints in the long-term study supported the finding that the efficacy of sofpironium was maintained until week 52 of treatment.…”

“…Japanese patients with primary axillary hyperhidrosis who participated in the confirmatory study 10 and completed 6‐week treatment with a treatment compliance rate of 80% or more were included in this study.…”

“…In the preceding 6-week confirmatory study of sofpironium (multicenter, randomized, double-blind, vehicle-controlled, parallelgroup study), 139 and 140 Japanese patients with primary axillary hyperhidrosis in the vehicle and sofpironium groups completed study treatment, respectively. 10 Of these patients, 185 patients who provided written informed consent and met the eligibility criteria for the present long-term treatment study (94 patients in the vehicle group and 91 patients in the sofpironium group in the 6-week confirmatory study) started to receive sofpironium, and enrollment was then terminated during the registration period, because the target sample size (185 patients) was achieved.…”

“…We previously conducted a phase III study to verify the efficacy and safety of 5% sofpironium bromide gel (hereinafter referred to as sofpironium) administrated for 6 weeks in Japanese patients with primary axillary hyperhidrosis, and demonstrated the efficacy and safety of sofpironium. 10 In September 2020, sofpironium (ECCLOCK ® gel 5%; Kaken Pharmaceutical Co., Ltd., Japan) was approved in Japan for the topical treatment of primary axillary hyperhidrosis. However, sofpironium had not been administrated for more than 6 weeks, and the safety and efficacy of long‐term treatment of sofpironium had not been studied.…”

A glycopyrronium bromide 1% cream for topical treatment of primary axillary hyperhidrosis: efficacy and safety results from a phase IIIa randomized controlled trial*

“…The percentage of PROM responders at the EOT was 48·2% (SB) vs. 26·4% (vehicle; P < 0·001), while the proportion of subjects with a ≥ 50% reduction in the rate of gravimetric sweat production from baseline to EOT was 77·3% (SB) vs. 66·4% (vehicle; P = 0·042). 33 , 35 …”