DARA BioSciences Receives Fast Track Designation From the U.S. FDA for KRN5500 for the Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer

DARA BioSciences, Inc. DARA announced today that its investigational drug KRN5500 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer. The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address the unmet medical need (Fast Track Drugs). The purpose of the program is to get important drugs to the patient earlier. New Drug Applications (NDA) for products in the Fast Track program normally receive priority review. Information reported by the U.S. FDA states that for the years 1993 to 2003 the median time required to review a priority drug was reduced approximately by half vs. standard review. In addition, the FDA may now consider KRN5500's U.S. NDA submissions on a rolling basis. This process permits DARA to submit, and the FDA to review, sections of the NDA in advance of DARA's completing entire submission for marketing approval. The partial submission and review process may result in additional time saved. Fast Track status also entitles DARA to more frequent correspondence and meetings, which can facilitate faster answers to questions and additional assistance with development direction and study design.