FDA News

Inocoll Receives FDA Approval to Commence Phase 2 Clinical Development with its CollaRx BUPIVACAINE IMPLANT for the Management of Post-operative Pain

(April 5, 2007)-- Innocoll,  a privately-held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to conduct a Phase 2 clinical trial with its long-acting CollaRx(R) BUPIVACAINE IMPLANT for the management of post-operative pain in patients undergoing abdominal hysterectomy. The implant is a biodegradable and fully resorbable Bupivacaine-Collagen Sponge formulated using Innocoll's proprietary CollaRx technology. It is under development in the US and Europe for the management of post-operative pain following moderate/major abdominal, gynecological, thoracic or 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 difficulty breathing, sedation, nausea and vomiting and can affect patients' recovery. The CollaRx BUPIVACAINE IMPLANT is intended to provide pain control at the surgical site and thus reduce the level of additional analgesia required after surgery. The product is comprised of a fully biodegradable and bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine. The bioresorbable nature of the collagen matrix avoids the need for removal of a catheter by a healthcare professional, as is necessary for ambulatory infusion pumps often used to provide continuous, long-term analgesia. Furthermore, infusion catheters can fall out, shift, lead to infection and can be cumbersome during physical therapy.

A key feature of Innocoll's Bupivacaine implant is the ability to place it directly into the surgical vault and at different layers within the wound such as 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. In addition to pain relief, the collagen matrix also provides hemostasis and promotes wound healing after surgery.

Share or bookmarklet this web page at: