As was previously reported the drug known as 4975 demonstrated pain reduction at all pre-specified time intervals in the study.
New data from this study shows 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. 4975 demonstrated pain reduction for up to two weeks after knee replacement surgeries.
Post-operatively, all patients in the trial self-administered intravenous morphine via patient controlled analgesia pump approximately 48-hours following surgery. A trend toward lower morphine usage was demonstrated in the 4975-treated group versus the placebo-treated group.
This is an important finding, as an advantage of 4975 is its potential to reduce the need for opioid drugs, which are well known to have side effects.
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.
A follow-on phase II clinical trial in patients undergoing knee replacement surgeries is expected to begin during the first half of 2007. Anesiva plans to initiate a phase III trial in knee replacement surgery patients in the second half of 2007.