ASHBURN, Va., March 1 /PRNewswire/ -- Innocoll, Inc. announced that it has filed an Investigational New Drug (IND) application for its CollaRx(R) BUPIVACAINE IMPLANT, which is under development for the management of post- operative pain following moderate/major abdominal, gynecological, thoracic or orthopedic surgeries. The implant is a biodegradable and fully resorbable Bupivacaine-Collagen Sponge formulated using Innocoll’s proprietary CollaRx technology.
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 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 pain pumps. Furthermore, ambulatory pain pumps 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. The collagen matrix naturally biodegrades over a few days and the bupivacaine is released to provide sustained local analgesia. In addition to pain relief, the collagen matrix also provides haemostasis and promotes wound healing after surgery.
Under the IND, Innocoll initially plans to conduct a, three-way, multi- centered phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynecological cancers. The trial will compare the analgesic effect of the bupivacaine implant versus a placebo implant and current standard of care, and follows the initial phase 2 trial in the same surgery currently ongoing at Wexham Park Hospital, Slough, UK. The preliminary results of the ongoing trial are particularly encouraging. Commenting on the UK trial, the Principal Investigator, Mr. P.W. Reginald, said “To date all patients have responded very well to treatment. These observations indicate that the bupivacaine sponge is providing the desired analgesic effect and patient outcomes have been most convincing.”
Pain has been designated as the ‘5th vital sign’ by the WHO and 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. Hysterectomy is the second most common major surgery among women in the United States and each year, more than 600,000 hysterectomies are performed. About one third of women in the United States have had a hysterectomy by age 60. Hysterectomy is just one of many surgeries where Innocoll’s Bupivacaine Implant could potentially be used routinely; others may include moderate/major abdominal, thoracic or orthopedic surgeries.
Dr. Michael Myers, Innocoll’s President and CEO stated ‘We are very excited about the Bupivacaine Implant and consider it an excellent and complimentary follow-up to our marketed Gentamicin product used for the treatment and prevention of post-operative infections. We are particularly encouraged by the preliminary results from the ongoing UK trial and Mr. Reginald’s enthusiasm for the product. The Bupivacaine Implant offers us an attractive commercial opportunity and we now intend to prioritize its development in the US and Europe.”
About CollaRx(R) CollaRx is Innocoll’s lead technology platform for the site specific targeted delivery of a wide variety of drugs with particular emphasis on antibiotics and anesthetics. The CollaRx technology also forms the basis of Innocoll’s lead product, Gentamicin Surgical Implant, a biodegradable leave-behind implant indicated for the treatment and prevention of post- surgical acquired infection in both hard and soft tissues. This product has been approved in over 40 countries in Europe, Latin America, Middle East, Africa and Asia and is marketed under the following trade names; COLLATAMP(R) G, COLLATAMP(R) EG, SULMYCIN(R) IMPLANT, GARAMYCIN(R) SCHWAMM, DURACOL(R), DURACOLL(R), GENTACOL(R), GENTACOLL(R), GARACOL(R), GARACOLL(R), and CRONOCOL(R).
About Innocoll, Inc.
Innocoll is a privately held, fully integrated, global, hospital specialty pharmaceutical company specializing in surgical and dermatological products. It develops and markets internationally a range of medical products using its proprietary collagen-based technologies, CollaRx(R) and LiquiColl(R). Innocoll acquired the product rights for Gentamicin Surgical Implant from Essex Chemis AG, an affiliated company of Schering-Plough Corporation and has since assumed all sales, marketing and distribution activities for the product. For more information, please visit www.innocoll.com.
Innocoll Inc
CONTACT: Martha Clancy, Corporate Communications Officer of Innocoll,Inc., +353-0-906-634902, mclancy@innocoll-tech.com
Web site: http://www.innocollinc.com/
