Adlea is a long-acting, non-opiate analgesic drug candidate designed to provide pain relief for weeks to months after a single local application during the surgical procedure.
The trial will enroll approximately 160 patients, randomized to receive either a single 15mg dose of Adlea or placebo instilled into the surgical wound prior to closure. The trial will evaluate safety, tolerability, pharmacokinetics and the ability of Adlea to reduce post-operative pain following total hip replacement surgery.
John McLaughlin, CEO of Anesiva, said: “Hip replacement surgery can involve a long recovery time sometimes up to six months which is frequently accompanied by post-operative pain from the procedure. We believe Adlea may help alleviate the resulting pain for patients without the troubling side effects that other treatments such as opiates and COX-2 inhibitors can cause. We believe that these benefits can help patients recover faster and complete their rehabilitation more successfully after surgery.”