The company has previously released positive results from a Phase II (DTCL100) trial evaluating KRN5500, which demonstrated reduction of pain and safety and was superior to placebo.
Based largely on these positive findings, the National Cancer Institute (NCI) is partnering with Dara to initiate a second Phase II study, which it anticipates will commence later this year.
Dara chairman and CEO Richard Franco said 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.