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Positive Results Reported From Two Phase 3 Clinical Trials of Fentanyl Buccal Tablet in Opioid-Tolerant Patients With Neuropathic Pain
One double-blind, placebo-controlled study assessed the efficacy of Fentora in a variety of chronic conditions associated with neuropathic pain. The study involved 75 opioid-tolerant patients and demonstrated statistically significant improvement as measured on the primary endpoint, the Sum of Pain Intensity Differences at 60 minutes (p Similar results were reported for a second double-blind, placebo- controlled study that evaluated the onset of pain relief with Fentora in 78 opioid-tolerant patients with cancer. Earlier clinical trials submitted as part of the Fentora New Drug Application began evaluating pain relief at 15 minutes. This new study looked at earlier time points and demonstrated statistically significant differences in pain relief compared with placebo at 10 minutes (p "These new studies of Fentora provide strong support for our clinical development strategy in breakthrough pain in additional chronic pain conditions," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "These data further suggest that, in opioid-tolerant patients, the onset of pain relief from Fentora may be more rapid than indicated in the approved labeling."
Fentora is currently approved by the FDA for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. At this time, it is not approved for the management of breakthrough pain associated with other chronic pain conditions. Cephalon expects to seek regulatory approval for an expansion of the labeled indications for Fentora, which will include data from Phase 3 studies in patients with chronic pain conditions associated with breakthrough pain, such as neuropathic and low back pain.
Breakthrough pain is a component of chronic pain that is characterized by its rapid onset, moderate to severe intensity, and relatively short duration. It is estimated that 64 percent of patients with cancer - and 74 percent of patients with conditions other than cancer - who are treated for persistent pain will experience breakthrough pain.
Approved to manage breakthrough pain in opioid-tolerant patients with cancer, Fentora's drug delivery system generates transient changes in pH that may optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. The most commonly observed adverse events seen in all Fentora clinical studies are typical of opioid adverse events. Opioid adverse events should be expected and managed accordingly. In clinical trials of Fentora, the most common (.10%) adverse events were nausea, dizziness, vomiting, fatigue, headache, constipation, somnolence, anemia, and dehydration. Most adverse events were mild to moderate in severity. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms.