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DARA Biosciences Inc Announces Submission Of Krn5500 To FDA For Orphan Designation


Thursday, 29 Nov 2012 08:00am EST 

DARA Biosciences Inc announced it has submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for KRN5500, a compound in development to treat a painful form of chronic chemotherapy-induced peripheral neuropathy (CCIPN). The FDA provides orphan drug status to products that treat rare conditions for which there may be few adequate therapies. No approved treatments currently exist for CCIPN. Orphan designation qualifies the drug developer for tax credits, the waiver of the prescription drug user fee and seven-year market exclusivity. DARA engaged consultants with extensive FDA experience to guide the preparation of the Orphan Drug Application. In October 2011, the FDA designated KRN5500 a "Fast Track" drug. The Fast Track process expedites the development and review of drugs that treat serious diseases and fill an unmet medical need. Fast track designation may support accelerated approval of such drugs, and orphan designation would provide seven year exclusivity on KRN5500 for the orphan indication. KRN5500 is an intravenously administered, non-opioid analgesic with rapid onset of action and prolonged pain mitigation, as demonstrated in both pre-clinical and clinical studies. KRN5500 is being developed to treat the painful form of CCIPN. Painful CCIPN is characterized by the persistence of chemotherapy-associated pain for at least twelve weeks after chemotherapy has stopped. 

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