SOUTH SAN FRANCISCO, Calif., June 3 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that the South Korea Food and Drug Administration has approved Anesiva's investigational new drug application for Adlea(TM), 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. Anesiva 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 U.S. 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 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 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.
How Adlea May Address the Need for Long-Duration, Well-Tolerated Pain Relief
Adlea is a long-acting, non-opioid drug with the potential to provide pain relief for weeks to months after a single localized treatment. Its novel mechanism of action results in site-specific efficacy intended to avoid the unwanted side effects associated with systemically administered analgesic drugs such as opioids and NSAIDs.
Adlea is a highly purified form of capsaicin (derived from chili peppers) that acts primarily on TRPV-1 receptors residing on C-fiber neurons which transmit long-term pain by binding to and desensitizing these pain receptors. This leads to a prolonged, reversible and localized desensitization of the pain fibers. The drug generally has a short half-life of 1 to 2 hours, and is undetectable in the blood after 24 hours.
Adlea's short duration of systemic exposure relative to the longer duration of analgesia may offer a safe, additive treatment option in the management of post-surgical orthopedic pain, as well as pain due to moderate to severe osteoarthritis. In clinical trials to date, adverse events have been similar in patients receiving Adlea or placebo.
About Anesiva and its Diverse Pipeline of Pain Products
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(TM), for the reduction of pain associated with peripheral venous access procedures in children ages three to 18. In clinical trials, the most common adverse reactions to Zingo were redness (erythema), red dots (petechiae) and swelling (edema). The next product in Anesiva's pipeline, Adlea(TM), is currently in two pivotal Phase 3 clinical trials to support an indication for the management of acute pain following orthopedic surgery. Adlea has been shown to reduce pain after only a single administration for weeks to months in multiple settings in mid-stage clinical trials for site-specific, acute and chronic, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.
Forward Looking Statements
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward- looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: the timing and results of our clinical trials, and our regulatory approval strategy for Adlea. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's annual report on Form 10-K for the year ended December 31, 2007 and most recently quarterly report on Form 10-Q.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
SOURCE Anesiva, Inc.