DARA BioSciences, Inc. (NASDAQ:DARA) today announced the Journal of Pain and Symptom Management, an internationally respected, peer-reviewed journal, has published results of a Phase II safety and efficacy study of KRN5500 for the treatment of neuropathic pain in patients with cancer. The study showed KRN5500 demonstrated a statistically significant improvement in the relief of neuropathic pain versus placebo. The Phase II trial was designed as a double-blind, placebo-controlled, randomized, dose escalation study. Refractory neuropathic pain of any etiology was acceptable for study entry. Refractory was defined as failure to achieve adequate relief from at least two commonly used treatments for neuropathic pain. The FDA recently designated KRN5500 as a Fast Track Drug. The 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 unmet medical need.
At study endpoint, KRN5500 exhibited a significant median decrease in pain intensity from baseline of 24% compared with 0% for placebo.
The journal article concludes, "KRN5500 demonstrated safety at dose levels providing first therapeutic evidence for treatment-resistant (refractory) neuropathic pain in patients with advanced cancer, although causing transient GI side effects that were generally manageable. Despite the relatively small sample size, statistically significant and clinically meaningful improvements in pain were observed in patients treated with KRN5500 when compared to placebo."
"The continuing recognition of KRN5500's potential as an important treatment for a very difficult condition is extremely gratifying. First, KRN5500 was granted FAST Track drug designation by the US FDA and now to have results of this clinical study published in a well recognized, peer-reviewed journal is exceptional," said Richard A. Franco, Chairman and CEO of DARA BioSciences.
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