Orphan Drug Application Submitted for Chemotherapy-induced Peripheral Neuropathy Drug
DARA BioSciences announced it has submitted an Orphan Drug Application to the FDA for KRN5500, a compound in development to treat painful chronic chemotherapy-induced peripheral neuropathy (CCIPN). KRN5500 is an intravenously administered, non-opioid analgesic (spicamycin derivative) with rapid onset of action and prolonged pain mitigation.
In October 2011, the FDA designated KRN5500 a "Fast Track" drug.
Painful CCIPN is characterized by the persistence of chemotherapy-associated pain for at least twelve weeks after chemotherapy has stopped.
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