Anesiva Announces Clinical Trial Of Adlea For Reducing Post-Surgical Pain Following Knee Replacement
Anesiva's pivotal Phase 3 clinical trial evaluating Adlea, its long-acting, non-opioid analgesic drug candidate, in patients following total knee replacement surgery, is underway.
In September 2007, Anesiva initiated a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the safety and efficacy of a single 5 or 15 mg dose of Adlea or placebo administered into the surgical site in patients undergoing total knee replacement surgery. Having completed enrollment of the initially planned 80 patients, Anesiva has converted this trial into a Phase 3 trial by expanding the planned enrollment by approximately 134 patients for a total sample size of 214, increasing the number of trial sites, and focusing enrollment on the 15 mg and placebo groups.
"Total knee replacement is a commonly performed orthopedic surgery that can significantly enhance patients' quality of life," said Keith Candiotti, M.D., Associate Professor of Clinical Anesthesiology and Internal Medicine; Director of Clinical Research, Chief, Division of Perioperative Medicine, University of Miami Leonard M. Miller School of Medicine, and investigator in the Phase 3 study. "The effective management of post-surgical pain is critical since patients must begin walking and moving the knee soon after the procedure in order to begin recovery and avoid complications. Adlea may offer additive pain relief and possibly reduce the use of other pain medications such as opioids, whose systemic side effects can interfere with the recovery process."
The primary efficacy endpoint of the Phase 3 trial is a time-weighted pain score (using a standard 0 - 10 numerical rating scale of pain intensity) from four to 48 hours following knee replacement surgery. The study will also evaluate pain scores during the first two weeks following surgery, as well as opioid consumption. The safety of Adlea will be evaluated throughout the study.
"We now have two pivotal Phase 3 trials in progress for Adlea, in total knee replacement surgeries and bunionectomy surgeries, and expect to have top-line data from both by year-end," said John P. McLaughlin, chief executive officer of Anesiva. "We also are conducting a Phase 2 trial in total hip replacement surgeries and plan to initiate a Phase 2 trial in arthroscopic shoulder surgeries to support a broad label of pain management following orthopedic surgery."
Anesiva has previously completed Phase 1 and 2 trials of Adlea in total knee replacement and bunionectomy surgeries, as well as in osteoarthritis of the knee, elbow tendonitis and Morton's neuroma.