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news.DARA BioSciences has filed an orphan drug application with the US FDA for KRN5500 to treat a painful form of chronic chemotherapy-induced peripheral neuropathy (CCIPN).
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When administered intravenously, KRN5500 acts immediately and provides prolonged pain mitigation.
DARA CEO David Drutz said KRN5500 demonstrated statistical and clinical superiority over placebo in a small Phase 2a clinical trial conducted in patients that had both advanced cancer and the painful form of CCIPN.
"It is important to note that each of the trial participants was also prescribed other pain medications, none of which alone or in combination had resulted in a reduction of pain due to CCIPN," Drutz added.
The company even simplified KRN5500 formulation for easier administration at the bedside by directly adding to an IV bag and filed new patents.