DARA BioSciences Receives Fast-Track Designation for KRN5500
DARA BioSciences, Inc. recently announced its investigational drug KRN5500 has been granted Fast-Track designation by the US FDA for the treatment of chemotherapy-induced neuropathic pain in patients with cancer.
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 (p = 0.03). Based largely on these positive findings, the National Cancer Institute (NCI) is partnering with the company to initiate a second Phase II study, which it anticipates will commence later this year.
“We see a lot of patients with chemotherapy-induced neuropathic pain,” said Amy P. Abernethy, MD, Director of the Duke Cancer Care Research Program at the
“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% to 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.”
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