Earlier today, DARA BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted an expedited approval for the company’s experimental drug KRN5500 intended to treat neuropathic pain induced by chemotherapy in cancer patients.
In a Phase II trial (DTCL100), KRN5500 is said to have achieved the study goal and attained positive results for pain reduction and safety, thus establishing its superiority over placebo (p=0.03). In view of the promising positive results, the National Cancer Institute (NCI) is collaborating with DARA to kick off a second Phase II study that is expected to commence later this year.
Director of the Duke Cancer Care Research Program at the Duke University Medical Center Amy P. Abernethy, M.D., said: “We see a lot of patients with chemotherapy-induced neuropathic pain. They are a group of people that I find personally distressing to treat because they’ve got such difficult problems and many of them actually have long lives ahead of them, but have severe pain problems. No matter where they are in the course of their illness I think that KRN5500 holds promise as a potential help.”
Chairperson and CEO of DARA BioSciences, Richard A. Franco, RPh, added: “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. This is a most serious condition in need of new treatment options. Current estimates show as many as 40-50% of cancer patients receiving chemotherapy endure this condition and a certain portion of these patients endure relentless chronic pain requiring treatment even after they recover from their cancer. CIPN is also a dose limiting side effect of many commonly used chemotherapeutics. We are very encouraged by the initial clinical results, our partnership with the National Cancer Institute (NCI) and now the FDA Fast Track Drug status.”
The Fast Track program developed by the FDA is intended to facilitate the expedited review of new drugs (Fast Track Drugs) that can treat grave or potentially fatal conditions, and those with the capability to tackle unmet medical needs to ensure easy and early availability of these drugs to patients.
Generally, new Drug Applications (NDA) receive precedence and undergo expedited review in the Fast Track Program. The U.S. FDA notes that between 1993 and 2003, the average time for priority drug reviews had decreased to almost half the time necessitated for a standard drug review.
The FDA regards the NDA submissions for KRN5500 on a rolling basis. This implies that DARA can present sections of the NDA in advance rather than the FDA having to assess an entire submission for marketing approval, thereby saving precious time. Furthermore, owing to the fast track status, DARA will be entitled to recurrent correspondence and meetings, expedited query resolution process, and acquiring additional support for study design and development.