For the planned series of Phase II multi-centered, controlled clinical trials to be performed in the US, Innocoll has appointed Premier Research Group to co-ordinate up to five 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 patients undergoing abdominal hysterectomy commenced dosing in December 2007.
This second trial will compare the analgesic effect of Bupivacaine surgical implant versus a placebo implant in patients undergoing open mesh herniorrhaphy at five different US sites. Innocoll’s Bupivacaine surgical implant is 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. It is under development in the US and Europe for the management of post-operative pain following moderate or major abdominal, gynecological, abdominal, thoracic, and orthopedic surgeries.
Michael Myers, president and CEO of Innocoll, said: “The dosing of this second Phase II trial with our Bupivacaine Implant for the management of post-operative pain follows closely behind other Phase II and Phase III trials recently initiated with our topically-applied Gentamicin-Collagen sponge for the treatment of infected diabetic foot ulcers and our Gentamicin surgical implant for the prevention of surgical site infection.”