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Fentanyl Pectin Nasal Spray Offers Fast Relief of Breakthrough Cancer Pain: Presented at APS

By Ed Susman

SAN DIEGO -- May 12, 2009 -- The use of fentanyl pectin nasal spray rapidly and effectively combats episodes of breakthrough cancer pain among patients who are tolerant of opioid medications, researchers reported here at the 28th Annual Scientific Meeting of the American Pain Society (APS).

"Treatment of breakthrough cancer pain represents an unmet need in therapy for patients with advanced cancer who sometimes experience periods of intense, debilitating pain that can not be predicted," said Allen Burton, MD, Department of Pain Medicine, University of Texas M.D. Anderson Cancer Center, Houston, Texas.

Dr. Burton and colleagues tested the use of fentanyl pectin nasal spray among patients who were recruited for a randomised, placebo-controlled, double-blind, crossover study conducted in the United States, Argentina, and Costa Rica.

The study analysed use of the treatment in 659 breakthrough cancer pain episodes, 459 of which were treated with the fentanyl nasal spray and 200 of which were treated with a placebo spray.

After a 10-day screening period 83 patients entered the 2-week titration period, and 76 patients completed the 2-month study.

"In some cases, the patients experiencing breakthrough pain were able to get relief within 5 minutes using this nasal spray," Dr. Burton said at his poster presentation on May 8.

He said that breakthrough pain typically can last up to about an hour, and standard rescue mediations can take most of that time to become effective. Breakthrough cancer pain often occurs even though patients are already taking opioid medication for chronic pain caused, most often, by cancer that has metastasised to bone.

The researchers found that 33% of the patients who were using fentanyl pectin nasal spray achieved relief in pain intensity within 5 minutes compared with 26.5% of placebo use (P = .05); 61% of the patients using the active spray achieved meaningful pain intensity relief at 10 minutes compared with 44% of those on placebo (P < .0001); and 73.2% of patients on fentanyl achieved pain intensity relief at 15 minutes compared with 55.5% of patients on placebo (P < .0001).

The treatment-related adverse events were more frequent with fentanyl pectin nasal spray than placebo, but were mainly consistent with the pharmacological profile of fentanyl, Dr. Burton said. "No significant nasal effects were reported," he said.

Funding for this study was provided by Archimedes Development Limited.

[Presentation title: Fentanyl Pectin Nasal Spray With PecSys: Onset of Action, Consistency, and Acceptability in Breakthrough Cancer Pain. Abstract 140]

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