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Effervescent Fentanyl Tablets Effective for Breakthrough Cancer Pain: Presented at AAPM

By Crystal Phend

SAN DIEGO, C.A. -- February 27, 2006 -- A new fast-acting effervescent formulation of fentanyl appears to effectively control breakthrough pain for opioid treated patients with cancer, researchers said here at the annual meeting of the American Academy of Pain Medicine (AAPM).

Although fentanyl, a potent mu receptor opiate, has been used for many years, the effervescent tablet form belongs to the next generation of rapid onset opiates, said presenting author Donald Taylor, MD, Medical Director, Comprehensive Pain Care, P.C., Marietta, Georgia, United States during a presentation on February 23^rd.

Bicarbonation improves the drug's lipid solubility so it can cross the cell membrane into the bloodstream faster. Patients in the study started to feel the effects of the fentanyl within 3 minutes and had pain relief within 10 minutes, Dr. Taylor said.

By comparison, breakthrough cancer pain above the chronic level often reaches peak intensity within minutes and is typically treated with short-acting opioids like oxycodone that starts to relieve pain within 35 to 40 minutes.

In the initial open-label phase of the study, 123 patients with cancer-related chronic pain were titrated up to a dose of study drug between 100 mcg and 800 mcg that controlled their breakthrough pain within 30 minutes.

In the double blind phase, patients were randomized to a sequence of tablets (three placebo and seven fentanyl at the predetermined effective dose) to be given for breakthrough pain episodes over the 21 day study phase.

Pain intensity difference over the first 30 minutes after taking a tablet -- the primary efficacy measure -- was significantly better for the study drug than placebo. Pain intensity differences, both mean and over a 60 minute period, and pain relief were also significantly superior at every time point starting at 15 minutes with effervescent fentanyl compared to placebo.

Patients were twice as likely to require medication to supplement the tablet when placebo was used.

Adverse events were typical of those for fentanyl and were at a "quite acceptable level," Dr. Taylor said.

"The drug truly does what it's supposed to do," Dr. Taylor said.

Cephalon sponsored the study.


[Presentation title: A Randomized, Placebo-Controlled Study of Fentanyl Effervescent Buccal Tablets for Breakthrough Pain in Opioid-Treated Patients With Cancer. Poster 115]

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