Fentanyl buccal tablets effective for breakthrough pain.
Of 197 patients who used the tablets for up to a year, 80% said they preferred them to the pain medication they took previously for breakthrough pain, said Dr. Sharon Weinstein, professor of anesthesiology at the University of Utah, Salt Lake City.
"Breakthrough pain occurs in 60%-90% of opioid-tolerant patients with chronic, persistent cancer-related pain that is generally controlled," Dr. Weinstein, director of the pain medicine and palliative care program at the Huntsman Cancer Institute in Salt Lake City. The fentanyl buccal tablets (Fentora, Cephalon Inc.) are easy for patients to take and can be used safely and effectively over the long term for relief of breakthrough cancer pain, she said.
The study enrolled 110 treatment-naive patients and 122 patients who were rolled over from two previous clinical trials of the tablet. All had been on an around-the clock regimen of 60-1,000 mg/ day of morphine or 25-300 mcg/ hour of transdermal fentanyl for persistent cancer pain and were having one to four episodes of breakthrough pain a day.
They had used a variety of drugs to control breakthrough pain, including hydro morphone, oxycodone, hydrocodone, morphine, and fentanyl citrate.
The treatment-naive patients were individually titrated to a successful tolerated does, which ranged from 100 to 800 mcg of fentanyl per tablet. The rollover patients remained on their established fentanyl buccal tablet doses, which were in a similar range.
After the titration phase, which lasted 3 weeks, 197 patients went on to the maintenance phase, which lasted 12 months.
The patients were surveyed by quetionnaire and asked whether they preferred the fentanyl buccal tablet or their previous breakthrough pain medicine, and 158 patients (80%) said they preferred fentanyl buccal tablets. In addition, 177 patients (90%) said the time to onset of pain relief was faster with the tablets, and 118 patients (60%) said the tablets were more convenient to use than their previous medications.
There was one incident of drug with drawal syndrome, but no other treatment related serious adverse events occurred. The most common adverse events associated with fentanyl buccal tablet use were nausea, vomiting, fatigue, constipation, anemia, and peripheral edema.
During the study, 56 patients required a does increase, 11 required a decrease, and 2 required both an increase and a decrease, Dr. Weinstein said. The tablets allow the patient and the provider to very finely adjust the time course of action of the drug to the pain. "This allows [for] short-term relief when they need it and not as much accumulation of drug when they are not having as much pain."
In September 2007, the Food and Drug Administration issued a Public Health Advisory, warning about deaths and other adverse events associated with their use. When asked to comment on the warning, Dr. Weinstein said, "Opioids are generally safe and effective when properly prescribed and used according to directions under appropriate medical supervision. The deaths reported by the FDA were the result of improper selection of patients".
Fetanyl Buccal Tablets vs. Other Breakthrough Pain Medications * Faster onset of pain relief 90% Preferred 80% More convenient 60% * Oxycodone, hydrocodone, morphine, hydromorphone, and fentanyl citrate. Note: Based on a survey of 197 patients after 1 year of fentanyl buccal use. Source: Dr. Weinstem
Dr. Weinstein disclosed she had no financial conflicts of interest. Cephalon Inc. sponsored the study.
BY FRAN LOWRY