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