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news.Anesiva has initiated a Phase II clinical trial of Adlea, a long-acting, site specific, non-opioid drug candidate for the management of acute pain in patients undergoing arthroscopic shoulder surgery involving rotator cuff repair.
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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.
The Phase II arthroscopic shoulder surgery trial is being conducted in South Korea. Unlike the US, 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.
Adlea is currently in two pivotal Phase III trials in the US: one in total knee replacement surgeries and one in bunionectomy surgeries. An additional Phase II 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.
Michael Kranda, president and CEO of Anesiva, said: “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.”