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Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain
Date:1/4/2008

ontinuous, long-term analgesia at the site of a surgical wound.

Innocoll has recently completed a phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynecological cancers at Wexham Park Hospital, Slough, UK. The results of this trial were particularly encouraging, showing evidence of sustained, post-operative analgesia for approximately 96 hours as measured by VAS (visual analogue scale) scores and reduced dependence on systemic morphine administered by PCA (patient- controlled analgesia). This extended action was achieved despite a low total bupivacaine dose (150mg as the hydrochloride salt), which is well below the allowable daily dose and equivalent to that used by some practitioners for a once-off wound infiltration with bupivacaine solution prior to wound closure.

For the planned series of phase 2 multi-centered, controlled clinical trials to be performed in the US, Innocoll has appointed Premier Research Group, a recognized industry leader in clinical research for acute and chronic pain, 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 2 soft tissue trials in herniorrhaphy and open gastrointestinal surgeries are expected to commence in early 2008.

About one third of women in the US have a hysterectomy by age 60 and each year, more than 600,000 hysterectomies are performed across the country. Other procedures where the product could potentially be used routinely include caesarean section, inguinal hernia repair, open-heart surgery, mastectomy, open gastrointestinal surgery, cholecystectomy, vascular surgery, and various ortho
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