On February 25, 2014, DARA BioSciences, Inc. (DARA) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to KRN5500 for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy (CCIPN) that is refractory to conventional analgesics. This is enormously positive news for the company. DARA first filed the ODD application back in November 2012, so it's been fifteen long months of back-and-forth with the agency over the iterative process. We most recently wrote about the potential for DARA to receive ODD on KRN5500 in December 2013, calling the designation a potential game-changer for the company. Below we provide some background on KRN5500 and outline how ODD helps greatly improve economic value of...
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