2021-01-19 07:38:47 BBI Brickell Biotech
01/19/21 01/1907:38 01/19/2107:38 | Brickell announces Japan Phase 3 study results for sofpironium bromide gelBrickell Biotech announced that the efficacy and safety results from the pivotal Phase 3 study conducted in Japan by its development partner, Kaken Pharmaceutical were published in the peer-reviewed Journal of Dermatology. The paper, entitled "A phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study of 5% sofpironium bromide gel in Japanese patients with primary axillary hyperhidrosis," is available online in English at the Wiley Online Library. Kaken and Brickell first announced the release of the Japan pivotal Phase 3 study results in June 2020. Subsequently, Kaken received regulatory approval to manufacture and market ECCLOCK in Japan for the treatment of primary axillary hyperhidrosis in September 2020 and launched commercial sales in November 2020. Japan is the first country to approve sofpironium bromide, which also marks the first approval of a topical prescription product for the treatment of primary axillary hyperhidrosis in Japan. In addition, Brickell recently initiated its U.S. pivotal Phase 3 clinical program evaluating sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis. Brickell expects to report topline data from the U.S. pivotal Phase 3 program in the fourth quarter of 2021. |
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