Aspen, Colo. – At the most recent edition of The Cosmetic Bootcamp (CBC), an expert discussed the safety and efficacy of prabobotulinumtoxinA in clinical trials to date.
The similarity of response curves in the U.S., European and Canadian studies shows consistency, said Kenneth Beer, M.D. “Sometimes when you do multicenter trials, one trial won’t look anything like the other. That means there’s a problem.”
In the American EV-001 and EV-002 pivotal trials, he said, both response curves mirror each other, with 67% and 71% of patients meeting the primary clinical endpoint at day 30. These response curves also vary greatly from the placebo response rate at that point – approximately 1%.
Adverse events were mild and very rare in all 3 prabobotulinum studies, said Dr. Beer. Because the product met all primary endpoints in Phase 3, with a high degree of safety, he predicted it will reach the US market before long.
Dr. Beer is associate clinical professor of dermatology at the University of Miami Miller School of Medicine, consulting associate with Duke University, clinical associate in dermatology, University of Pennsylvania Perelman School of Medicine and a CBC cofounder.
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