ASHBURN, Va. and ROSCOMMON, Ireland, Mar 28 /PRNewswire/ -- Innocoll, Inc. announced today that its Drug Delivery Division, Innocoll Technologies Ltd., has initiated a Phase IIA clinical study on the Bupivacaine collagen sponge under development for the management of post-operative pain following moderate/major abdominal, gynecological, thoracic or orthopedic surgeries. The study will be conducted in patients undergoing hysterectomy surgery in the absence of gynecological cancers. The main objective of the study is to determine the safety and tolerability of the product with an initial assessment of pain control. The study will examine the effects of the Bupivacaine collagen sponge on variables including the patients' level of pain and amount of additional analgesia needed to control pain.
Post-surgical pain is often controlled with narcotic analgesics such as morphine, but these drugs can result in unfavorable side effects including difficulty breathing, nausea and vomiting and can affect patients' recovery. Innocoll's Bupivacaine collagen sponge is intended to provide pain control at the surgical site and thus reduce the level of additional analgesia required after surgery. The Bupivacaine collagen sponge is comprised of a fully biodegradable and bioresorbable matrix of purified fibrillar atelocollagen impregnated with the local anesthetic, Bupivacaine. The sponge is designed for implantation directly into the surgical cavity and can be placed at different levels of the wound to provide pain relief to all affected areas. The collagen matrix naturally biodegrades over a few days and the Bupivacaine is released to act exactly where it's needed. In addition to pain relief, the collagen matrix provides haemostasis and promotes wound healing after surgery.
Pain has been designated as the '5th vital sign' by the WHO and is significantly under-treated worldwide. 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. In the UK, over 130,000 hysterectomies are conducted each year. This is just one of the areas that Innocoll's Bupivacaine collagen sponge will target and independent market research has estimated peak global sales of more than $150 million.
According to the Principal Investigator, Mr. P.W. Reginald of Wexham Park Hospital, Slough, UK, one of the key features of Innocoll's product is the ability to place the sponge directly into the surgical vault and at different layers within the wound for example across the incision in the peritoneum and between the sheath and skin around the incision. This is one of the main advantages of the product in addition to the bioresorbable nature of the collagen matrix, which avoids the need for removal of a catheter as is the case of the ambulatory pain pumps. Ambulatory pain pumps can fall out, shift, lead to infection, must be removed by a healthcare professional and can be cumbersome during physical therapy.
Dr. Michael Myers, Innocoll's President and CEO stated that, "The initiation of this study is a milestone for the company. The Bupivacaine collagen sponge is the second CollaRx(TM) product in human clinical studies, following Collatamp(R) G, which has been marketed for over 20 years and is now registered in over 50 countries. Post-operative pain management is a poorly met medical need and we are excited about the development of our bioresorbable Bupivacaine collagen sponge, which will not only provide pain relief but will also offer convenience for both the surgeon and the patient."
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(TM) and LiquiColl(R). Innocoll, Inc. acquired the product rights for Collatamp G 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 http://www.innocoll.com . For product or pipeline information, please visit http://www.innocoll-pharma.com .
About Innocoll Technologies
Innocoll Technologies is responsible for the development of new products based upon the existing CollaRx and Liquicoll platform technologies and for research into new collagen-based medicinal products and medical devices. Our internal programs are focused on treatment and prevention of surgical site infections, advanced wound care, post-operative pain management, prevention of surgical adhesions and oncology. We are also seeking co-development partnerships with pharmaceutical and biotechnology companies interested in using our technologies to develop first-line products or localized delivery line extensions of existing brands.
Innocoll, Inc.CONTACT: Michelle Cox, Marketing Manager of Innocoll Pharmaceuticals,+353-(0)-90-648-6282 or mcox@innocoll-pharma.com
