CollaRx® Bupivacaine Implant
Pain has been designated as the ‘5th vital sign' by the WHO. Post-operative pain is often poorly controlled and widely considered as a poorly met medical need. Every year over 150 million people undergo surgery and billions of dollars are spent on post-operative pain management. Post-surgical pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavorable side effects including difficulty breathing, sedation, nausea and can slow down patient recovery.
Innocoll's CollaRx® Bupivacaine Implant has been designed to provide long-lasting pain relief directly at the surgical site and is intended to reduce the level of additional analgesia required post-operatively. The bioresorbable nature of the CollaRx matrix offers significant clinical and convenience advantages over continuous infusion devices such as ambulatory pain pumps.
A key feature of Innocoll's product is the ability to place it at different levels within the wound, such as directly into the surgical cavity, across the incision in the peritoneum and between the sheath and skin around the incision. This enables the effective, localized treatment of both the incisional and deep, visceral pain components associated with moderate and major surgery. 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.
Innocoll first conducted a clinical trial in patients undergoing hysterectomy surgery at Wexham Park Hospital, Slough, UK. The results of this trial were particularly encouraging, showing evidence of sustained, post-operative pain control as measured by VAS (visual analogue scale) and reduced dependence on morphine by PCA (patient-controlled analgesia). Innocoll has since commenced a series of US multi-centered phase II clinical trials in a variety of surgical models including hysterectomy, herniorraphy, and open gastrointestinal surgery.