CollaRx® Gentamicin Topical
An estimated 15% of patients with diabetes develop a lower extremity ulcer during the course of their disease. Practically all ulcers are colonized with pathogenic bacteria, and a high proportion become clinically infected requiring treatment with antibiotics. Orally administered and injected antibiotics are often associated with systemic side effects and widespread use leads to development of bacterial resistance. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow (ischemia), which may render systemically acting antibiotics less effective. According to a large prospective study, approximately 7% of diabetic patients with foot ulcers require an amputation. Diabetic foot is the most common cause of nontraumatic lower extremity amputations in the US and Europe, with an average of 82,000 amputations per year in the US costing an estimated $1.6 billion annually. The estimated cost of foot ulcer care in the US ranges from $4,595 per ulcer episode to more than $28,000 and the total annual cost of foot ulcer care in the US has been estimated to be as high as $5 billion.
Published clinical case studies and anecdotal reports from clinicians outside the US using Innocoll's CollaRx® Gentamicin Surgical Implant topically suggest it is highly effective in the treatment of infected chronic wounds such as diabetic foot and venous stasis ulcers. Currently, there are no topically applied antibiotics marketed in the US that are specifically indicated for this application.
Innocoll is developing CollaRx® Gentamicin Topical for the treatment and prevention of diabetic foot infections of varying severities, as defined according to the clinical classification in the IDSA Guidelines. The company has initiated 3 separate phase II studies to evaluate the safety and efficacy of the product to treat and prevent various degrees of infection in diabetic foot ulcers. The three studies are designed to evaluate the following:
- The treatment of diabetic foot ulcers with a mild infection where CollaRx Gentamicin Topical will be compared to an orally administered antibiotic, the current standard of care.
- The treatment of moderately or severely infected diabetic foot ulcers, as an adjunct to systemic therapy.
- The prevention of at-risk ulcers from becoming clinically infected.
The product has been partnered in all territories outside of the US. Innocoll is currently evaluating out-licensing options for the product in the US.