Fentora supplemental new drug application (sNDA) includes data from three randomized, placebo-controlled clinical trials and one long-term open-label safety study with a total of 941 opioid tolerant patients. The patients in the Fentora sNDA trials were treated for up to 18 months and had a broad range of underlying chronic pain conditions, including chronic low back and chronic neuropathic pain. The FDA’s typical review period for a sNDA is 10 to 12 months.
Dr Lesley Russell, executive vice president, worldwide medical and regulatory operations, said: “The clinical trials supporting this submission mark the first time a pain medication has been evaluated as a treatment for breakthrough pain associated with serious chronic pain conditions other than cancer. We look forward to working with FDA to broaden the use of Fentora to opioid tolerant patients with unresolved debilitating breakthrough pain.”