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news.Biopharmaceutical firm Corgentech has completed patient enrollment in three phase II clinical trials of Algrx 4975, a non-opioid pain management drug candidate, to evaluate this novel agent's ability to reduce post-surgical pain.
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The three trials each enrolled approximately 40 patients who have either undergone cholecystectomy, hernia repair or total knee replacement surgery. In all three trials, patients were randomized to receive either Algrx 4975 or placebo, which was administered before closure of the surgical wound to reduce post-surgical pain, and thus reduce the need for opioid drugs and hasten recovery time.
Algrx 4975 is long-acting and designed to provide pain relief to patients for weeks or months after just a single treatment. The drug, a VR1 agonist, is based on capsaicin and acts as a C-neuron anesthetic. The product is administered locally at the site of pain and selectively reduces pain in nerve endings so does not affect other nerve fibers important for other sensory or motor skills.
“In multiple clinical trials to date, Algrx 4975 has been shown to reduce post-surgical, neuropathic and musculoskeletal pain for weeks to months after a single administration,” stated Dr Patricia Richards, vice president, clinical research at Corgentech. “There is a major unmet need for well-tolerated, long-acting pain relievers that could reduce the need for opioid medications, and we look forward to sharing the results of all these trials in the second quarter of 2006.”
In addition to the post-surgical studies underway, Algrx 4975 is being evaluated in a phase II study for Morton’s neuroma, a neuropathic condition of the foot, and in a phase II trial for tendonitis. In a phase II study of bunionectomy patients, Algrx 4975 demonstrated months of pain relief following bunionectomy surgeries.