SOUTH SAN FRANCISCO, Calif., July 17 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that it has begun a Phase 2 clinical trial of Adlea(TM), the company's long-acting, site specific, non-opioid drug candidate for the management of acute pain in patients undergoing arthroscopic shoulder surgery involving rotator cuff repair.
Adlea is currently in two pivotal Phase 3 trials in the U.S.: one in total knee replacement surgeries and one in bunionectomy surgeries. An additional Phase 2 Adlea trial is in progress in total hip replacement surgeries. These trials are among those intended to support an Adlea label indication for the management of acute pain following orthopedic surgery.
The Phase 2 arthroscopic shoulder surgery trial is being conducted in South Korea. Unlike the United States, where the procedure is often conducted on an outpatient basis, arthroscopic shoulder surgery patients in South Korea are routinely hospitalized for up to two days, thus allowing more extensive near-term follow-up.
"We believe Adlea holds promise for treating pain associated with a number of orthopedic surgical indications, and may reduce the need for other pain treatments such as opioids," said Michael L. Kranda, Anesiva's president and chief executive officer. "As we pursue a broad indication of management of post-surgical pain following orthopedic procedures, each specific procedure that we can evaluate will add to the breadth of available data for Adlea."
Arthroscopic surgery is performed through small incisions using an arthroscope, or camera, to visualize the inside of a joint. Through the incisions, a surgeon inserts a camera and small instruments to perform the procedure. According to the American Academy of Orthopedic Surgeons, about six million Americans go to the doctor each year for shoulder pain, dislocation, or other shoulder problems and up to 500,000 arthroscopic shoulder surgeries are performed in the United States each year.
This multicenter, randomized, double-blind, dose-escalating, placebo-controlled study is evaluating the safety, tolerability, efficacy, and pharmacokinetics of a single dose of Adlea administered via injection following surgical closure of the wound. The trial is designed to enroll 74 patients.
Anesiva announced approval of its investigational new drug application for Adlea in South Korea in June 2008.
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 analgesia, which has the potential to reduce the use of and minimize the 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 C-fiber neurons, which transmit long-term pain, by binding to and desensitizing the TRPV1 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. The company's first commercial product, Zingo(TM), is available in the U.S. for the reduction of pain associated with peripheral venous access procedures in children ages three to 18.
The next product in Anesiva's pipeline, Adlea(TM), is currently being evaluated 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.|
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