Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, today reported that based on a meeting held last week with the U.S. Food and Drug Administration (FDA), the Company plans to begin its Phase 3 program in December 2012 in support of a New Drug Application (NDA) for DSC127 for treatment of diabetic foot ulcers. The FDA has expressed concurrence with the Company’s Chemistry, Manufacturing and Controls (CMC) program.
“We had a productive meeting with the FDA and are working to finalize components of the development program discussed with the Agency during the meeting. The Agency provided helpful guidance, which our development team is now incorporating into our studies. We maintain our goal of beginning our Phase 3 program before the end of the year,” said Edward J. Quilty, president and chief executive officer of Derma Sciences. “Importantly, our drug manufacturing can proceed, and is in the final testing stage with the first doses expected to be available next month. We were very pleased with our discussion with the FDA and with the Agency’s recognition that the healing of diabetic foot ulcers represents a significant unmet medical need.”
About Diabetes and Diabetic Foot Ulcers
According to the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, diabetes affects 25.8 million people of all ages, or 8.3% of the U.S. population and nearly 2 million new cases are diagnosed yearly in people age 20 or older. More than 60% of non-traumatic lower-limb amputations occur in people with diabetes and in 2006, about 65,700 non-traumatic lower-limb amputations were performed in people with diabetes. About 80% of amputations were preceded by a foot ulcer. In 2007, the total cost, both direct and indirect attributed to diabetes was $174 billion in the U.S. alone and was the seventh leading cause of death. The International Diabetes Foundation estimates that 366 million people worldwide had diabetes in 2011 and that by 2030 this will have risen to 552 million.