FDA grants Fast Track designation for DARA's KRN5500 neuropathic pain relief drug

DARA BioSciences, Inc. (NASDAQ: 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.

DARA earlier reported positive results of its Phase II clinical trial (DTCL100), which met its primary endpoints of reduction of pain and safety and was superior to placebo.

Amy P. Abernethy, M.D., Director of the Duke Cancer Care Research Program at the Duke University Medical Center said, "We see a lot of patients with chemotherapy-induced neuropathic pain. They are a group of people that I find personally distressing to treat because they've got such difficult problems and many of them actually have long lives ahead of them, but have severe pain problems. No matter where they are in the course of their illness I think that KRN5500 holds promise as a potential help."

"The FDA Fast Track designation for KRN5500 is a significant positive step for the thousands of cancer patients who suffer this unremitting pain from a number of causes including from their chemotherapy," said Richard A. Franco, RPh, Chairman and CEO of DARA BioSciences. "This is a most serious condition in need of new treatment options. Current estimates show as many as 40-50% of cancer patients receiving chemotherapy endure this condition and a certain portion of these patients endure relentless chronic pain requiring treatment even after they recover from their cancer. CIPN is also a dose limiting side effect of many commonly used chemotherapeutics. We are very encouraged by the initial clinical results, our partnership with the National Cancer Institute (NCI) and now the FDA Fast Track Drug status," he added.

Source: DARA BioSciences, Inc.

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