Anesiva, Inc. announced that the South Korea Food and Drug Administration has approved Anesiva's investigational new drug application for Adlea, the company's long-acting, site specific, non-opioid drug candidate in phase 3 clinical development for the management of acute pain following orthopedic surgery.
According to an Anesiva press release, the company plans to initiate a phase 2 clinical trial of Adlea in patients undergoing arthroscopic shoulder surgery in South Korea this summer.
"We selected South Korea for this Adlea clinical trial because the standards of care in orthopedic surgery and the professional training of its clinicians are similar to those in the United States," said John McLaughlin, chief executive officer. "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 United States."
The planned study is a multicentre, 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 enrol 74 patients.
Adlea is currently in two pivotal Phase 3 trials in the U.S.: one in total knee replacement surgeries and one in bunionectomy surgeries. Top-line data from both trials are expected by year-end 2008. An additional Phase 2 Adlea trial is in progress in total hip replacement surgeries. These trials are among those intended to support a broad Adlea label indication for the management of acute pain following orthopedic surgery.
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel pharmaceutical products for pain management. Anesiva has one FDA-approved product, Zingo, for the reduction of pain associated with peripheral venous access procedures in children ages three to 18.