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ANESIVA PRESENTS DATA ON POSTOPERATIVE PAIN DRUG

February 12, 2007

Anesiva has presented positive data from a Phase II trial in total knee replacement surgeries with drug candidate 4975, the company's novel, long-acting, non-opioid drug being developed for site-specific, moderate-to-severe pain.

The trial demonstrated pain reduction at all prespecified time intervals in the study. The data showed a trend toward lower concomitant morphine usage in the 4975-treated group over the placebo group, one of multiple secondary endpoints. The study also met its primary objective of safety and tolerability.

"Following our successful meeting with the FDA, we now have a clear development pathway for 4975 and are focusing our near-term efforts in two areas -- postsurgical pain and pain associated with osteoarthritis -- both areas in which 4975 has shown its ability to reduce pain following just a single administration," Daniel Gennevois, senior vice president of clinical development at Anesiva, said.

The study involved 50 knee replacement surgery patients who were randomized to receive either a single dose of 4975 or placebo, which was dripped by syringe into the wound prior to closure. All patients in the trial received progressive multimodal analgesia. Additionally, all patients in the trial self-administered intravenous morphine via a patient-controlled analgesia pump to achieve satisfactory analgesia for approximately 48-hours following surgery, and a trend toward lower morphine usage was demonstrated in the 4975-treated group versus the placebo-treated group.

This is an important finding, as opioid drugs are known to have side effects such as sedation, respiratory depression, euphoria, and nausea and vomiting during acute use, according to the company. In clinical studies to date, 4975 has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated.

The company plans to launch a follow-on Phase II during the first half of 2007 to evaluate a higher dose of 4975. Anesiva then plans to initiate a Phase III trial during the second half of the year.