DARA Biosciences Inc. (Nasdaq: DARA) shares climbed 23.3% to $2.81, on word of a fast-tracking for its new pain drug. Volume for the stock topped 835,000 shares Thursday morning, crushing its all-day average of 28,000.
A news release out August 18 revealed that the Raleigh, North Carolina-based DARA announced today that its investigational drug KRN5500 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer.
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address the unmet medical need (Fast Track Drugs). The purpose of the program is to get important drugs to the patient earlier.
New Drug Applications (NDA) for products in the Fast Track program normally receive priority review.
The same release quoted DARA CEO Richard Franco as saying, “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,” Franco continued. “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,” he added.