Innocoll, a privately-held biopharmaceutical company, has announced that the FDA has designated Gentamicin surgical implant as a fast track development program.
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.
Innocoll has previously entered into an exclusive license and distribution agreement with Baxter Healthcare for its Gentamicin surgical implant for the US 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. The product was developed using Innocoll's collagen-based drug delivery technology, CollaRx, and 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.
Michael Myers, CEO of Innocoll, said: "We are very pleased that the FDA has granted the product fast track status which recognizes that the product is intended to prevent a serious or life-threatening condition and represents an unmet medical need. We look forward to working closely with Baxter to register and commercialize the product in the US, which will provide surgeons across a broad range of surgical specialties with more options for their patients."