Navigation Links
Innocoll Announces Dosing of Last Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-Operative Pain
Date:8/8/2008

ASHBURN, Va., Aug. 8 /PRNewswire/ -- Innocoll, Inc., a privately-held biopharmaceutical company, announced that the last patient has been dosed in the first of three ongoing phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the management of post-operative pain.

Innocoll's BUPIVACAINE SURGICAL 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 proprietary CollaRx sponge technology. It is under development in the US 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 thus reduce the level of additional analgesia required following 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. 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 peritoneal 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 bioresorbable nature of the collagen matrix also offers significant clinical benefits and convenience advantages over ambulatory infusion pumps which can be used to provide continuous, long-term analgesia at the site of a surgical wound.

Innocoll has already completed a phase 2 clinical trial in patients undergoing hysterectomy surgery in the absence of gynecological cancers at Wexham Park Hospital, Slough, UK. 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 analgesic 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.

Innocoll has appointed Premier Research Group, a leading clinical research organization in acute and chronic pain, to co-ordinate a series of US phase 2 multi-centered, controlled clinical trials in a variety of surgical procedures; including hysterectomy, herniorrhaphy, and open gastrointestinal surgery. In addition to those surgeries currently being studied, other procedures where the product could potentially be used routinely include caesarean section, mastectomy, cholecystectomy, open heart surgery, vascular surgery, and various orthopedic surgeries such as hip and knee replacement, bunionectomy, open fracture repair and certain bone graft procedures.

This trial, the first of three ongoing multi-centered trials to complete patient enrollment, is a 3-way study comparing the analgesic effect of BUPIVACAINE SURGICAL IMPLANT versus placebo and standard of care in patients undergoing total abdominal hysterectomy.

Dr. Michael Myers, Innocoll's President and CEO commented "We are delighted to have enrolled the last patient in this phase 2 trial and we are now eagerly anticipating the full and final results in approximately 3 months. In the meantime, we are working diligently through our other ongoing and planned phase 2 and phase 3 clinical trials to support the development of our three leading product opportunities in post-operative pain, prevention of surgical site infection, and treatment of diabetic foot infection."

About Innocoll, Inc.

Innocoll is a privately-held biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. It develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). Innocoll 's lead product, Gentamicin Surgical Implant for the treatment and prevention of surgical site infections, is approved for sale in 49 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). In 2005, Innocoll acquired the worldwide marketing rights for this product from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP) and in August 2007 sold its marketing rights with the exception of the US, to EUSA Pharma. Gentamicin Surgical Implant is currently in phase 3 development in the US for the prevention of surgical site infections. Other late stage pharmaceutical products in Innocoll's development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit http://www.innocollinc.com.


'/>"/>
SOURCE Innocoll, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Prevention of Diabetic Foot Infections
2. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Moderately Infected Diabetic Foot Ulcers
3. Innocoll Announces Dosing of First Patient in Second US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections
4. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain
5. Innocoll Announces Dosing of First Patient in US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections in Cardiac Surgery Patients
6. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) GENTAMICIN TOPICAL for the Treatment of Mildly Infected Diabetic Foot Ulcers
7. Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
8. Amicus Therapeutics Announces Second Quarter 2008 Financial Results
9. Oramed Pharmaceuticals Announces Successful Phase 2A Clinical Trial of its Oral Insulin Capsule
10. Rib-X Pharmaceuticals, Inc. Announces Recent and Upcoming Presentations at Scientific Conferences
11. Tolerx Announces Achievement of Milestones upon anti-CD4 Antibody Program Advancement and Initiation of Phase 1 Clinical Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... RIDGEFIELD, Conn. , Dec. 8, 2016  Boehringer ... the 2017 Corporate Equality Index (CEI). This is the ... and has been designated as a Best Place to ... Campaign Foundation, the CEI is a national benchmarking report ... for lesbian, gay, bisexual and transgender (LGBT) employees. ...
(Date:12/8/2016)... , Dec. 8, 2016  Avelas Biosciences, Inc., ... cancer patient care from diagnosis through treatment, today ... completed Phase 1b study in breast cancer patients ... Antonio Breast Cancer Symposium. Jonathan Unkart , ... UC San Diego Health, delivered the presentation titled ...
(Date:12/8/2016)... , Dec. 8, 2016  Hanson Research, an ... dissolution testing and diffusion testing instruments for the ... by Teledyne Instruments, Inc. ("Teledyne"). The move is ... of precision testing instruments, as well as expand ... of new products and services. Logo - ...
Breaking Medicine Technology:
(Date:12/8/2016)... ... December 08, 2016 , ... The West Virginia Medical ... 2017. The name change aligns the entire company with its existing Quality ... quality. , “We are very proud of the achievements associated with the West ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... Institute (WCRI) officially opened registration today for its 33rd Annual Issues & ... MA . , The theme of the conference is “Persistent Challenges and New ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... announce that “Natural Language Processing–Enabled and Conventional Data Capture Methods for Input to ... Medical Informatics . , Results of the comparative usability study demonstrate that a ...
(Date:12/8/2016)... ... 08, 2016 , ... Mirixa Corporation , a leading ... pharmacist-delivered patient care services, has announced the promotions of Karen Litsinger to senior ... of sales. , Litsinger joined Mirixa in 2008 after serving as a ...
(Date:12/8/2016)... ... ... With the increasing demand for dental implants, the National Association of Dental ... dentists and patients about the safety issues related to dental restorations. According to the ... is projected to reach $6.4 billion in 2018 with more than 30 million Americans ...
Breaking Medicine News(10 mins):