The bupivacaine surgical implant is under development in the US and Europe for the management of post-operative pain following moderate/major abdominal, gynecological, abdominal, thoracic, and orthopedic surgeries.
Innocoll has appointed Premier Research Group, a recognized industry leader in clinical research for acute and chronic pain, to co-ordinate up to five US Phase II multi-centered, controlled clinical trials in a variety of soft and hard tissue procedures; including hysterectomy, herniorrhaphy, open gastrointestinal surgery and orthopedic surgery.
The first of these trials in women undergoing abdominal hysterectomy commenced dosing in December 2007 and the second in men undergoing inguinal hernia repair commenced dosing in March 2008. This third multi-centered trial will compare the analgesic effect of bupivacaine surgical implant versus placebo in patients undergoing open gastrointestinal surgery.
Innocoll’s bupivacaine surgical implant is said to be a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine, which has been specifically developed and formulated using Innocoll’s proprietary CollaRx sponge technology.
Michael Myers, president and CEO of Innocoll, said: “The dosing of this third Phase II trial is an important milestone in the development of our bupivacaine implant for the management of post-operative pain.”