Cephalon, Inc, announced that it has received approval from the US Food and Drug Administration (FDA) to market fentanyl(Drug information on fentanyl) buccal tablets (Fentora [C-II]) 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. The product is the first and only buccal tablet approved for this indication.
"Research on breakthrough pain conducted over the past 15 years suggested that we needed to look beyond conventional short-acting opioids and evaluate new medications that could better manage the rapid onset of this often debilitating condition," said Russell Portenoy, MD, chairman, department of pain medicine and palliative care, Beth Israel Medical Center, New York, and a principal investigator in the buccal fentanyl clinical trials. "The clinical trials of Fentora confirm that it is safe and effective for cancer-related breakthrough pain, and may relieve pain faster than orally ingested opioids."
Conventional short-acting oral opioids, often used to treat breakthrough pain, are swallowed and absorbed in the gastrointestinal tract, which can take up to 30-45 minutes to take effect. With Fentora's drug delivery technology, approximately half of the medicine is absorbed directly across the lining of the upper cheek, the buccal mucosa, and into the bloodstream more quickly than if it were swallowed and broken down by the liver in the gastrointestinal tract.
In placebo-controlled clinical trials, patients treated with fentanyl buccal tablets showed a statistically significant improvement on the primary endpoint, the Sum of Pain Intensity Differences (P < .01), and some patients experienced clinically significant decreases in pain intensity and greater pain relief within 15 minutes, the first time point measured. In addition, pharmacokinetic data indicate that systemic exposure to fentanyl occurred earlier and was approximately 30% greater with buccal fentanyl than with oral transmucosal fentanyl (Actiq). As such, buccal administration delivers the therapeutic benefit of fentanyl at a lower dose than transmucosal delivery.
Cephalon will manufacture the product in five dosage strengths: 100, 200, 400, 600, and 800 µg.