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news.Anesiva has announced that the South Korea Food and Drug Administration has approved the investigational new drug application for Adlea, the company's long-acting, site specific, non-opioid drug candidate in Phase III clinical development for the management of acute pain following orthopedic surgery.
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The planned study is a multicenter, randomized, double-blind, placebo- controlled, two-stage exploratory study to evaluate the safety, tolerability, efficacy and pharmacokinetics of a single dose of Adlea compared to placebo administered at the conclusion of arthroscopic shoulder surgery. The trial is designed to enroll 74 patients.
Adlea is currently in two pivotal Phase III trials in the US – one in total knee replacement surgeries and one in bunionectomy surgeries. Top-line data from both trials are expected by year-end 2008. Anesiva also plans to initiate a Phase II clinical trial of Adlea in patients undergoing arthroscopic shoulder surgery in South Korea this summer.
John McLaughlin, CEO of Anesiva, said: “An important difference from US clinical practice is that arthroscopic shoulder surgery patients in South Korea are routinely admitted to the hospital for two or more days following surgery. This extended hospitalization period will enable us to conduct longer and more detailed post-surgical safety and efficacy analyses than would be practical in the US.”