Researchers from the University of Utah have reported that fentanyl buccal tablets (FBT) (Fentora®) were effective and had a favorable safety profile for the management of patients with persistent cancer pain who had breakthrough pain on opioids. The details of this study appeared in an early online publication in Cancer on April 16, 2009.[1]

The control of pain related to cancer and cancer treatment is an important and often neglected part of cancer management. It is estimated that 30%-45% of patients will have moderate to severe pain in the early and intermediate stages of cancer and 70%-90% will have moderate to severe pain in the final stages of cancer. Cancer pain is better controlled in the hospital setting, but more and more patients with cancer are being treated in the outpatient department. There is evidence that many patients receive inadequate doses of opiates to control pain. In this era of multimodality treatment, it is also very important to coordinate pain management with several treating groups of physicians and nurses. Members of the American Pain Society (APS) published the first update of Quality Improvement Guidelines for the Treatment of Acute Pain and Cancer Pain to improve quality of care in 2005.

The current study evaluated the effectiveness of FBT tablets in 112 patients with breakthrough pain who were opioid-tolerant and had not been exposed to FBT and 120 patients who had been exposed to FBT in previous studies. All had cancer with an expected survival of over two months. A dose titration study was carried out in the FBT naïve group; 79 of these 112 patients had a successful dose determined. Seventy-seven of these 79 patients and the 120 patients (total=197) who had previously received FBT entered the maintenance phase of the study. Thirty-three percent of these 197 patients had FBT discontinued due to adverse events. Adverse events—with one exception—were related to the underlying cancer. The incidence of application site complications was 6%. These authors concluded: “FBT was generally well tolerated and had a favorable safety profile in the long-term (>12 months) management of patients with persistent cancer pain and breakthrough pain. No unexpected acute events occurred. Safety and tolerability was similar to that observed in short-term studies.”

Comments: FBT would appear to be a very effective way to treat opioid-tolerant patients with cancer pain. The effectiveness of FBT in treating breakthrough pain has been recently reviewed.[2] The main contribution of the present study is documentation of long-term effectiveness of FBT.

It is important to note that FBT should not be used in patients who are not opiate- tolerant. The FDA has issued a warning about the use of FBT for the treatment of short-term pain such as headaches and migraines, as deaths have been reported. The FDA has pointed out that FBT is not the same as other fentanyl products in that more drug is administered into the blood than in other formulations. This FDA information can be viewed at http://www.news-medical.net/?id=30443 or http://www.fda.gov/.

Reference: