New tablet manages breakthrough pain

November 20, 2006

The Food & Drug Administration recently approved fentanyl buccal tablets (Fentora, Cephalon) for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioids for their underlying persistent cancer pain. Fentora is the first and only buccal tablet approved for this indication and is the first tablet formulation of the opioid fentanyl. It is also the first new medication approved for the treatment of breakthrough pain in opioid-tolerant patients with cancer since 1998.

The Food & Drug Administration recently approved fentanyl buccal tablets (Fentora, Cephalon) for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioids for their underlying persistent cancer pain. Fentora is the first and only buccal tablet approved for this indication and is the first tablet formulation of the opioid fentanyl. It is also the first new medication approved for the treatment of breakthrough pain in opioid-tolerant patients with cancer since 1998.

The presence of carbonic acid drives down the pH, which helps dissolve the medication, Messina said. He added that the carbonic acid is then broken up into carbon dioxide and water, and the resulting loss of carbon dioxide increases the pH, which favors absorption of the drug. The technology in Fentora permits about half of the medicine to be absorbed directly across the buccal mucosa and into the bloodstream, without first being metabolized by the liver, he said.

Russell Portenoy, M.D., chairman of the department of pain management and palliative care at Beth Israel Medical Center in New York City, concurred, adding that Fentora's bioavailability is approximately 30% higher than that of OTFC. When patients are converted from other oral fentanyl products, including OTFC, he said, Fentora should not be substituted on a microgram-per-microgram basis. Fentora actually delivers an analgesic effect at a lower dose than OTFC, Messina said.

The recommended starting dose of Fentora is 100 mcg. The company advises that dosing may be repeated once during a single episode of breakthrough pain. Cephalon also said that re-dosing may occur 30 minutes after the start of administration of Fentora and that the same dosage strength should be used.

The manufacturer recommends that to reduce the risk of overdose during titration, patients should have only one strength of Fentora tablet available at any one time.

Cephalon also recommends that those taking moderate or potent CYP3A4 inhibitors concomitantly with Fentora be monitored closely for an extended period and that dosage increases of Fentora be done conservatively. Finally the company suggests that the lowest possible dose of Fentora be used in those with renal and/or hepatic impairment.

Fentora is supplied in 100-, 200-, 400-, 600-, and 800-mcg strengths. The product is packaged in cartons containing 28 tablets.

Messina said that phase III trials of Fentora in those with breakthrough pain associated with back pain and neuropathic pain are ongoing.

TIPS TO REMEMBER Fentora

THE AUTHOR is a writer based in New Jersey.