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FDA Approves New Percocet Strengths With Lower Acetaminophen Doses

CHADDS FORD, PA -- November 26, 2001 -- Endo Pharmaceuticals Holdings Inc. announced the Food and Drug Administration's approval of the abbreviated new drug application to market Percocet® 7.5/325 and 10/325 oxycodone/acetaminophen tablets that was filed by Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings.

Percocet, the leading brand of oxycodone/acetaminophen on the market, is indicated for the treatment of moderate to moderately severe pain. The new reformulated Percocet 7.5/325 and 10/325 strengths offer proven pain relief with reduced acetaminophen content as compared with previously available formulations of the pain-relieving drug.

Carol A. Ammon, president and CEO of Endo Pharmaceuticals stated, "The new reformulated Percocet 7.5/325 and 10/325 underscore the strengths of Endo in the marketplace. We believe that we have a a robust pipeline that feeds into our growing marketing and sales organization, and the gold standard in pain management with our Percocet products.

"These new formulations were developed in response to physician demand. These formulations combine the higher strengths of 7.5 and 10 milligrams of oxycodone that physicians have increasingly adopted, with up to 50% less acetaminophen per day than previous formulations. This reinforces Endo's commitment to providing a broad range of safe and effective pain management products," Ms. Ammon said.

"With this new formulation, physicians can still take advantage of the synergistic action of the two analgesics combined, but without worrying about exceeding the daily limit of acetaminophen," said Nathaniel Katz, MD, Assistant Professor of Anesthesia at Harvard Medical School. "This will really be helpful to patients who may need higher doses of oxycodone to relieve their pain."

The new reformulated strengths, which are expected to be available in pharmacies within the next week to ten days, will potentially enable patients to take their Percocet on a simpler dosing schedule, allowing them to take fewer tablets per day, and less frequently than the original 5mg tablet. And due to the lower acetaminophen levels, these new strengths may allow physicians to prescribe Percocet 7.5/325 and 10/325 for more long-term use than previously acceptable.

"The new strengths continue to deliver the dual benefits of oxycodone and acetaminophen, while lowering the risk of excessive acetaminophen exposure," said Lori Reisner, Pharm.D. and Associate Clinical Professor of Pharmacy at the University of California in San Francisco. "The ever-increasing number of acetaminophen-containing products and other over-the-counter pain relievers requires pharmacists to be diligent in reminding physicians and patients about the appropriate level of usage."

The most frequently reported side effects of Percocet include lightheadedness, dizziness, sedation, nausea and vomiting. Oxycodone can produce drug dependence and has the potential for being abused. Physicians are reminded that the total daily dose of acetaminophen must be carefully considered in the use of any combination product.

SOURCE Endo Pharmaceuticals Holdings Inc.

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