Patients diagnosed with cancer are living longer than ever before as a result of greater awareness, earlier detection, and improvement in therapies. However, living longer also means facing the symptoms of cancer survivorship, which may have a considerable impact on quality of life for many patients. One such symptom is chemotherapy-induced neuropathic pain, a neurotoxic effect of some chemotherapeutic agents. Unfortunately, currently approved pain medications can have unbearable side effects that preclude the use of effective doses.
Positive results from a phase 2 study of a new medication for neuropathic pain in cancer patients, KRN5500, has been reported. Produced by Streptomyces alanosinicus, KRN5500 is a new spicamycin-derived, non-narcotic/non-opioid analgesic medication. A completed phase 2, double-blind, placebo-controlled, randomized, dose escalation study (DTCL100) generated positive results with respect to safety and efficacy of KRN5500 as treatment for neuropathic pain in patients with advanced cancer and neuropathic pain.
In light of the phase 2 study results and the current unmet medical need, the KRN5500 program was recently granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for treatment of chemotherapy-induced neuropathic pain. According to the FDA Web site, Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need.
“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,” said Richard A. Franco, RPh, Chairman and CEO of DARA BioSciences. “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,” he added.
Sources: DARA BioSciences, Inc; FDA.