Innocoll Receives Fast Track Designation for Gentamicin Surgical Implant
GENTAMICIN SURGICAL IMPLANT is currently being evaluated in two phase III clinical trials as an adjunct to systemic antibiotic administration for the prevention of surgical site infections in patients who are at higher risk of developing surgical site infections.
The FDA's fast track programs are designed to facilitate the development and expedite the review of new therapies that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. This summer, Innocoll entered into an exclusive License and Distribution Agreement with Baxter Healthcare Corporation for its GENTAMICIN SURGICAL IMPLANT for the U.S. market. Baxter has not yet determined a brand name for this product.
GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behind
surgical implant impregnated with the broad spectrum aminoglycoside
antibiotic, gentamicin. It is designed to provide a high concentration of
gentamicin (which has a concentration-dependent mechanism of action) directly
to the target tissue for localized action, while maintaining low systemic
levels well below the toxicity threshold. The product was developed using
Innocoll's proprietary collagen-based drug delivery technology, CollaRx, and
(outside of the U.S.) is indicated as an adjunct to systemic antibiotic
therapy for the treatment of localized, deep tissue infections and the
prevention of surgical site infections in both hard and soft tissues.
GENTAMICIN SURGICAL IMPLANT is already approved in 49 countries spanning
About Innocoll, Inc.
Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). 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 www.innocollinc.com.
SOURCE Innocoll, Inc.
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