The FDA has given Innocoll‘s (Dublin, Ireland) CollaRx® Gentamicin surgical implant fast track designation to speed through Phase III clinical trials. The device, thought to decrease risk of surgical site infection in patients with diabetes and obesity, has already received EU marketing approval.
From the product page:
CollaRx® Gentamicin Surgical Implant is a peri-operative surgical implant comprised of a lyophilized collagen matrix impregnated with the broad spectrum antibiotic, gentamicin (as the sulfate salt). The product utilizes Innocoll’s fully biocompatible and biodegradable CollaRx® sponge technology to deliver the gentamicin to the site of the infection or one at risk of infection.
CollaRx Gentamicin Surgical Implant achieves very high local concentrations of drug far in excess of the MIC (minimum inhibitory concentration) for gentamicin susceptible micro organisms (~ 4 μg/ml), yet maintains systemic levels while below the toxicity threshold (10 to 12 μg/ml). Gentamicin’s antibacterial action is concentration dependent and there is evidence to support that such high local concentrations (typically orders of magnitude above the MIC for the first 12 to 24 hours) can eradicate bacteria normally considered gentamicin resistant such as MRSE and MRSA. In addition to its antibacterial action, CollaRx Gentamicin Surgical Implant also benefits from the natural haemostasis and wound healing benefits of the fibrillar collagen sponge matrix.
And here’s what the company says about the clinical experience involving its implant:
We have been working closely with the FDA to establish the clinical program for this product, and following a pre-IND meeting in 2007, the product was immediately progressed to phase III based on the significant body of data that has been established in Europe, where the product is already marketed. The clinical program includes two phase III trials; the first in cardiac surgery patients at higher risk of surgical site infection. The design of this first phase II trial in diabetic and/or obese patients undergoing cardiac surgery is based upon a recently published 2,000 patient clinical trial demonstrating that the Company’s Gentamicin Surgical Implant reduced the incidence of sternal wound infection (SWI) by 53% for all patient populations when used as an adjunct to standard infection prophylaxis. Sub-population analysis of known high risk groups showed even greater treatment effect, most notably a 68% reduction in SWI for patients with diabetes. The second phase III trial is being conducted in patients undergoing colorectal surgery, which is an approved and well established use of the product in Europe. Several such studies have been published, including one prospective, randomized, controlled clinical trial in over 200 patients. The results of this trial showed a 70% decrease in surgical site infections from 18.4% in the control group to 5.6% in the patients treated with the Gentamicin Surgical Implant in conjunction with systemic therapy.
Product page: CollaRx® Gentamicin Surgical Implant – US …
Press release: Innocoll Receives Fast Track Designation for Gentamicin Surgical Implant …