January 4, 2008 - Pharmaceutical company Innocoll Inc. said today that the first of a series of planned phase 2 clinical trials to investigate the CollaRx Bupivacaine Surgical Implant for the management of post-operative pain, has commenced dosing.
Innocoll’s 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 CollaRx sponge technology. It is under development in the U.S. and Europe for the management of post-operative pain following moderate/major abdominal, gynecological, abdominal, thoracic, and orthopedic surgeries.
Post-operative pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavorable side effects including suppression of breathing, sedation, nausea and vomiting, and can also affect patient recovery. Innocoll’s Bupivacaine Surgical Implant is intended to provide pain control directly at the surgical site and reduce the level of additional analgesia required following surgery. The company says the collagen matrix naturally biodegrades over a few days and the bupivacaine is released to provide local analgesia for up to 96 hours post-operatively. A key feature of Innocoll’s product is the ability to implant it directly into the surgical cavity and at different layers within the wound, such as across the peritoneum incision and directly below the skin incision, which enables localized treatment of both the incisional and deep, visceral pain components normally associated with moderate and major surgery. The company also said the bioresorbable nature of the collagen matrix also offers significant clinical benefits and convenience advantages over ambulatory infusion pumps often used to provide continuous, 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, U.K. 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 U.S., 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 the implant versus a placebo implant and current standard of care in patients undergoing abdominal hysterectomy at eight different U.S. sites. The other phase 2 soft tissue trials in herniorrhaphy and open gastrointestinal surgeries are expected to commence in early 2008.
For more information: www.innocollinc.com