BOULDER — Brickell Biotech Inc. (Nasdaq: BBI) said its flagship anti-underarm-sweating treatment provided long-term efficacy in a Phase III trial in the U.S., which could be combined with another ongoing trial to move the drug toward approval for sale.
In a statement, the Boulder company said the final study for its sofpironium bromide ARGYLE determined that approximately 85% of volunteers experienced a one-point reduction on an existing four-point scale for underarm sweating severity and between 61% and 69% reported a two-point reduction.
However, approximately 22% of testers using 5% sofpironium bromide gel reported mild to moderate symptoms and just more than half of those testing the 15% version experienced some type of side effects.
The majority of those side effects were skin irritation in nature, but 4.9% of those using the lower-dose gel and 18.8% of those using the higher-dose gel reported having blurred vision.
The ARGYLE study is a long-term efficacy study that is expected to be included alongside the main Phase III study for sofpironium bromide that Brickell will use to ask federal drug regulators for approval to bring the drug to market.
© 2021 BizWest Media LLC
BOULDER — Brickell Biotech Inc. (Nasdaq: BBI) said its flagship anti-underarm-sweating treatment provided long-term efficacy in a Phase III trial in the U.S., which could be combined with another ongoing trial to move the drug toward approval for sale.
In a statement, the Boulder company said the final study for its sofpironium bromide ARGYLE determined that approximately 85% of volunteers experienced a one-point reduction on an existing four-point scale for underarm sweating severity and between 61% and 69% reported a two-point reduction.
However, approximately 22% of testers using 5% sofpironium bromide gel reported mild to moderate symptoms and just more than half of those testing the 15% version experienced some type of side effects.
The majority of those side effects were skin irritation in nature, but 4.9% of those using the lower-dose gel and 18.8% of those using the higher-dose gel reported having blurred vision.
The ARGYLE study is a long-term efficacy study that is expected to be included alongside the main Phase III study for sofpironium bromide that Brickell will use to ask federal drug regulators for approval to bring the drug to market.
© 2021 BizWest Media LLC
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