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The Phase 3 TKA trial, known as ACTIVE-2 (Assessment of highly purifiedCapsaicin To ImproVE pain management after orthopedic surgery), also showedthat Adlea's safety profile of adverse events, wound healing, and woundsensory function were similar to placebo over the study duration.
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"These compelling results confirm the analgesic contribution of Adleaduring the most critical period following total knee arthroplasty withsimultaneous opioid sparing effect, all without adding to the systemic side-effects commonly seen with opioids. These results suggest that Adlea has thepotential to facilitate early rehabilitation in the knee replacementpopulation," said William Houghton, M.D., Anesiva's senior vice president andchief medical officer.
"The ACTIVE-2 data convincingly validate the value of the Adlea asset andwill support our plans to partner or license this product candidate," saidMichael L. Kranda, Anesiva's president and chief executive officer.
"Over the past several months, we have revised the company's businessmodel to significantly reduce our burn rate, and will achieve our goal ofoperating largely as a virtual company by year-end," Mr. Kranda said. "We nowhave retained a dedicated team ideally suited for Adlea clinical developmentand partnering within a cost structure that is appropriate for the currentenvironment. With these positive developments, we look forward to rebuildingvalue for Anesiva through our virtual model, and through active partnering andlicensing programs."
ACTIVE-2 Details
This multicenter, double-blind, placebo-controlled trial enrolled 217patients undergoing total knee arthroplasty. Patients were randomized toreceive either a single 60 mL dose of Adlea (0.25 mg/mL drug concentration) orplacebo instilled into the surgical site immediately prior to wound closure.The primary efficacy endpoint was the area under the curve of patient painscores, using a standard 0 to 10 numerical weighting system from four to 48hours post-surgery. The study also evaluated rescue opioid consumption.Additional patient safety follow-up at two to six weeks after surgerydemonstrated an advantage in pain management for Adlea versus placebo, with asimilar safety profile.
Adlea Phase 3 Results in Bunionectomy Surgeries
A previous Phase 3 trial of Adlea, ACTIVE-1, in bunionectomy surgeries,demonstrated a highly statistically significant reduction in pain (p=0.004)from 4 to 48 hours post-surgery for Adlea-treated patients versus placebo,although the primary endpoint, pain at 4 to 32 hours post-surgery, narrowlyfailed to achieve statistical significance (p=0.07). The trial also achievedthe key secondary endpoint of reducing opioid use for Adlea versus placebo(p=0.012) over the four to 32 hour period, and Adlea was well-tolerated.
How Adlea May Address the Need for Long-Acting Pain Relief
Adlea is a highly purified form of capsaicin (derived from chili peppers)that acts on TRPV1 receptors, expressed most densely in C-fiber neurons.Importantly, desensitization of the TRPV1 receptors blocks noxious pain withno effect on adaptive pain or position sense. Adlea generally has a shorthalf-life of 1 to 2 hours. It is undetectable in the blood after 24 hours.
Adlea's short duration of systemic exposure (hours) relative to the longduration of analgesia may offer a safe, additive treatment option in themanagement of orthopedic post-surgical pain. Importantly, Adlea appears tohave a safety profile that is largely similar to placebo, in studies performedto date.
About Total Knee Arthroplasty
Total knee replacement (also known as total knee arthroplasty) isgenerally performed in patients with end-stage osteoarthritis of the knee.These patients have disabling pain which imposes severe limitations on theirmobility, and knee replacement is performed with the goal of relieving painand restoring mobility and knee function. There were an estimated 565,000total knee replacement procedures performed in the United States in 2006, andthe number of replacements will continue to grow as the average age of theU.S. population increases and as these individuals conduct more active lives.The American Academy of Orthopedic Surgeons projects that approximately 3.5million of these procedures will be done each year by 2030.
About Anesiva
Anesiva, Inc. seeks to be a leader in the development of novelpharmaceutical products for pain management. The company's lead productcandidate is Adlea, a novel small molecule formulation of capsaicin that iscurrently in development for the management of acute pain following orthopedicsurgeries. Adlea has been shown in previous clinical trials to provideextended pain relief after only a single administration in multipleindications for site-specific, acute and chronic, moderate-to-severe pain.
Anesiva is based in South San Francisco, CA. For more information, go towww.anesiva.com.
Forward-Looking Statements
This press release includes "forward-looking statements" within themeaning of the safe harbor provisions of the United States Private SecuritiesLitigation Reform Act of 1995. Words such as "seek," "expect," "estimate,""project," "achieve," "show," "demonstrate," "offer," "plan," "may," "will,""extend," "continue," and similar expressions are intended to identify suchforward-looking statements. Forward-looking statements in this press releaseinclude matters that involve known and unknown risks, uncertainties and otherfactors that may cause actual results, levels of activity, performance orachievements to differ materially from results expressed or implied by thispress release. Such risk factors include, among others: the nature and extentof additional Adlea clinical trials that may be required by the U.S. Food andDrug Administration prior to Anesiva's submission of an application forapproval to market Adlea, and whether any such additional trials will besuccessful. Actual results may differ materially from those contained in theforward-looking statements in this press release. Additional informationconcerning these and other risk factors is contained in Anesiva's annualreport on Form 10-K for the year ended December 31, 2007, and its most recentfiling on Form 10-Q.
SOURCE Anesiva, Inc.
