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Study Challenges High Estimate of Opioid-Tolerant Population

Started by ronr, February 03, 2009, 10:01:18 AM

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AAPM: Study Challenges High Estimate of Opioid-Tolerant Population
By John Gever, Senior Editor, MedPage Today
Published: February 02, 2009

HONOLULU, Feb. 2 -- The number of Americans taking maximal doses of opioid painkillers may be much smaller than previously estimated, a researcher said here.

From 2.2 to 2.6 million people in the U.S. had taken opioids at doses equivalent to 60 mg/day of morphine for more than 90 consecutive days, reported Arvind Narayana, M.D., of Cephalon in Frazer, Pa., at the American Academy of Pain Medicine meeting.

At that dosage level, patients are considered opioid-tolerant and ineligible for further dose escalations to control breakthrough pain, Dr. Narayana explained at a poster presentation.

Cephalon commissioned the study to clarify the actual prevalence of opioid tolerance, following testimony at an FDA advisory committee meeting indicating that 13 to 18 million Americans could be considered opioid-tolerant.

The prevalence of opioid tolerance is important to Cephalon because patients taking maximal doses of opioids are the target market for its buccal tablet formulation of fentanyl (Fentora).

The product is currently FDA-approved for treating breakthrough pain in opioid-tolerant cancer patients. Cephalon has sought additional approval for Fentora for breakthrough noncancer pain.

The FDA advisory committee meeting was held to consider the application last year.

Following the meeting, the FDA told Cephalon to beef up its previous risk management program for Fentora before approval for the broader indication would be granted.

Dr. Narayana said the new study's markedly smaller estimate is more plausible, as well as potentially helpful to alleviate the FDA's concerns about vast numbers of new Fentora prescriptions resulting from a broader approval.

He and his colleagues obtained insurance claims and prescription data from a large, private insurance database covering 54.7 million adults, of whom 14.3 million had prescriptions for opioids.

The largest number, 9 million, were taking hydrocodone, followed by oxycodone, propoxyfene, tramadol, and codeine.

Some 1.8 million appeared to be taking opioid medications daily, on the basis of the claims and prescription records, with 737,000 meeting the standard definition of opioid tolerance.

Extrapolated to the entire U.S. population, the researchers estimated that about 44 to 51 million people had received opioid prescriptions, 5.4 to 6.2 million were taking these agents daily, and 2.2 to 2.6 million could be regarded as opioid tolerant, Dr. Narayana said.

Primary source: American Academy of Pain Medicine
Source reference:
Narayana A, et al., "A healthcare claims database analysis to estimate the prevalence of chronic opioid use in adult patients in the United States" AAPM 2009; abstract 278.
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