Healthcare Industry News: total knee
News Release - October 10, 2007
Anesiva Defines Regulatory Pathway for Adlea with FDANew Phase 3 Plan Could Expedite Clinical Development Pathway
SOUTH SAN FRANCISCO, Calif., Oct. 10 (HSMN NewsFeed) -- Anesiva, Inc. (Nasdaq: ANSV ) today announced that it will conduct two Phase 3 clinical trials for the approval of Adlea(TM) -- one of which has already been planned in total knee replacement surgeries -- and the second trial in bunionectomy surgeries -- for a broad product label of management of post-surgical pain associated with orthopedic surgeries. This decision is the result of continuing conversations with the Food and Drug Administration (FDA). Adlea is the company's long-acting, non-opiate analgesic drug candidate designed to provide pain relief for weeks to months after a single local application during a surgical procedure. Anesiva has already demonstrated statistically significant pain reduction in Phase 2 trials in both of these settings. Both trials are expected to begin in the first half of 2008.
"We are very pleased with this agreement with the FDA. Some of our strongest clinical efficacy data for Adlea came from a Phase 2 bunionectomy trial of 185 patients, where Adlea resulted in statistically significant reductions in both post-surgical pain as well as the use of rescue medication," said John P. McLaughlin, chief executive officer of Anesiva. "Bunionectomy is an excellent choice for a second Phase 3 study because it is a well studied and validated pain model. In addition, bunionectomy studies are efficient and can be conducted rapidly."
Two prior randomized, double-blind, placebo-controlled Phase 2 bunionectomy trials evaluating the use of Adlea to reduce post-surgical pain yielded favorable results. The first trial was a Phase 2 study of 40 patients that suggested Adlea 1000ug was superior to placebo. The larger (n=185) phase 2 trial evaluated three dose levels of Adlea (100ug, 500ug and 1000ug) versus placebo. Dose response was demonstrated as follows: the Adlea 1000ug (concentration of 0.25 mg/mL) treated group demonstrated statistically significantly less pain in the first 32 hours following surgery (p = 0.0183) and a significantly lower proportion of patients requiring rescue medication (p = 0.0125) relative to placebo; the Adlea 500ug (0.125 mg/mL) treated group demonstrated a favorable trend both in pain rating and in the use of rescue medication. All three dosage levels of Adlea were shown to be well tolerated without safety concerns. In the Phase 3 program, an Adlea concentration of 0.25 mg/mL (1 mg instillation in bunionectomy and 15 mg in total knee arthroplasty) will be evaluated.
Anesiva is focused on two lead indications for Adlea: management of acute post-operative pain associated with orthopedic surgeries and management of osteoarthritis pain in the knee. Trials underway include a Phase 2 trial evaluating patients undergoing total knee and another trial in total hip replacement surgeries. Anesiva expects to initiate the following additional trials: a Phase 2 trial in arthroscopic shoulder surgery, a Phase 2 / 3 trial in osteoarthritis of the knee, and the two Phase 3 trials mentioned above for total knee replacement and bunionectomy surgeries.
How Adlea May Address The Need for Long-Duration, Well-Tolerated Pain Relief
Adlea is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, Adlea does not affect other nerve fibers necessary for sensory or motor sensations and proprioception.
Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, there appears to be limited systemic exposure. Its short duration of systemic exposure (hours) relative to the long duration of analgesia (weeks to months) resulting from a single treatment of Adlea is particularly important in this typically elderly and vulnerable patient population and may also potentially offer a safer treatment option in the management of chronic osteoarthritis pain. Importantly, the prolonged analgesic effect resulting from a single or stepped dose, localized administration of Adlea does not seem to be associated with the systemic side effects commonly associated with NSAIDs (gastrointestinal and renal toxicities, and impaired clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity), or opiates (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction). In clinical studies to date, Adlea has been shown to be well tolerated.
About Bunionectomy Surgeries
A bunionectomy is a surgical procedure to align the bones of the big toe joint thereby excising the bunion. A bunion is an enlargement of the joint at the base of the big toe caused by the misalignment of the big toe joint. It is usually a result of inflammation and irritation from poorly fitting (narrow and tight) shoes and is a condition that can be exacerbated by excessive standing or running. Bunionectomies are often performed as out-patient procedures enabling patients to go home the same day of their surgery.
About Anesiva and its Diverse Portfolio of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has one FDA-approved product, Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system, to reduce pain associated with peripheral venous access procedures in children three to 18 years of age. The second product in Anesiva's pipeline, Adlea(TM) (formerly 4975), has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, 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, whether Adlea will provide pain relief for weeks to months, whether Anesiva's bunionectomy studies will be efficient, whether Anesiva is able to manufacture our products on commercially reasonable terms, whether Anesiva can commercially release new products successfully and the degree to which these products gain market acceptance. 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 quarterly report on Form 10-Q for the quarter ended June 30, 2007.
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.
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