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news.Innocoll has reported that the first of a series of planned Phase II clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx Bupivacaine surgical implant for the management of post-operative pain, has commenced dosing.
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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 that has commenced dosing will compare the analgesic effect of Bupivacaine surgical implant versus a placebo implant and current standard of care in patients undergoing abdominal hysterectomy at eight different US sites. The other Phase II soft tissue trials in herniorrhaphy and open gastrointestinal surgeries are expected to commence in early 2008.
Innocoll’s Bupivacaine surgical implant is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery.
Michael Myers, president and CEO of Innocoll, said: “This first dosing with our Bupivacaine implant for the management of post-operative pain follows hot on the heels of other Phase II and Phase III trials 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.”