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news.Anesiva has started a pivotal Phase III clinical trial that will evaluate Adlea, its long-acting, non-opioid analgesic drug candidate, in patients following total knee replacement surgery.
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In September 2007, Anesiva initiated a multicenter, randomized, double-blind, placebo-controlled Phase II trial to evaluate the safety and efficacy of a single 5 or 15mg dose of Adlea or placebo administered into the surgical site in patients undergoing total knee replacement surgery. Having completed enrollment of the initially planned 80 patients, Anesiva has converted this trial into a Phase III trial by expanding the planned enrollment by approximately 134 patients for a total sample size of 214, increasing the number of trial sites, and focusing enrollment on the 15mg and placebo groups.
The primary efficacy endpoint of the Phase III trial is a time-weighted pain score (using a standard 0 – 10 numerical rating scale of pain intensity) from four to 48 hours following knee replacement surgery. The study will also evaluate pain scores during the first two weeks following surgery, as well as opioid consumption. The safety of Adlea will be evaluated throughout the study.
John McLaughlin, CEO of Anesiva, said: “We are also conducting a Phase II trial in total hip replacement surgeries and plan to initiate a Phase II trial in arthroscopic shoulder surgeries to support a broad label of pain management following orthopedic surgery.”