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Effervescent fentanyl subdues cancer pain.

SAN ANTONIO -- A new rapidly acting effervescent formulation of fentanyl appears to be safe and effective when used to treat breakthrough pain in cancer patients.

Results of preliminary research show that fentanyl effervescent buccal tablets (FEBT) may provide rapid-onset analgesia in patients with cancer-related breakthrough pain, which is usually treated with a short-acting opioid.

"This formulation is designed to enhance the rate and efficiency of fentanyl absorption through the buccal mucosa," Dr. Donald Taylor reported at the annual meeting of the American Pain Society.

Dr. Taylor, medical director of a group practice specializing in pain care in Marietta, Ga., and his colleagues evaluated the efficacy and tolerability of FEBT in 123 opioid-tolerant patients with chronic pain associated with cancer, in a double-blind, randomized, placebo-controlled study.

The Sum of Pain Intensity Difference (SPID), an outcome measure that summarizes treatment response, was evaluated during the first 30 minutes as the primary efficacy measure. The researchers also assessed pain at 45 and 60 minutes after delivery of the drug, evaluated patients' self-reported pain relief, and tracked the number of times patients required rescue medication.

Clinically significant decreases in pain intensity (33% or more) were observed in 13% of episodes at 15 minutes and in 48% of episodes by 30 minutes after drug delivery. At all end points, the percentage of episodes showing a decrease in pain intensity greater than 33% was significantly greater with FEBT than with placebo. After 30 minutes, pain intensity decreased by 50% or more with FEBT in 24% of episodes.

"We looked at about 500 breakthrough pain episodes and about half were relieved at 30 minutes, if you consider 'greater than 33%' to be relief," Dr. Taylor said. In all measurements, the analgesic effect of FEBT exceeded that of placebo.

In summary, FEBT produced a rapid onset of action and was superior to placebo. It was reasonably well tolerated and appears to be a relatively effective treatment for breakthrough pain in patients with cancer, he said.

BY ROXANNE NELSON

Contributing Writer
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Title Annotation:Neurology
Author:Nelson, Roxanne
Publication:Internal Medicine News
Geographic Code:1USA
Date:Aug 1, 2006
Words:332
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