Accentia: FDA approves Xodol, pain killer that combines hydrocodone, acetaminophen

By E. Janene Geiss

Philadelphia, March 30 - Accentia Biopharmaceuticals Inc.'s manufacturing partner received approval from the Food and Drug Administration for a new dosage of Xodol (hydrocodone bitartrate and acetaminophen tablets), the company's unique dosage of this combination pain product.

This new dosage affords physicians additional choices in the dose of hydrocodone for patients without exceeding the maximum daily dose of acetaminophen, according to a company news release.

Teamm Pharmaceuticals Inc., Accentia's wholly owned specialty pharmaceutical subsidiary, holds the exclusive U.S. license for the marketing and sale of this product.

"Xodol is a unique dosage product in that it combines an effective narcotic, hydrocodone, with a very commonly used analgesic, acetaminophen, in a lower dose of acetaminophen than is available in other combination pain medications," Gary Cantrell, executive vice president of sales and marketing for Teamm, said in the release.

Xodol combines hydrocodone and the lowest effective dose of acetaminophen, a formula that provides physicians with an effective pain-management combination, reducing the possibility that the patient will exceed the recommended daily allowance of acetaminophen, officials said.

The recommended daily dose of acetaminophen is up to 4,000 mg per day for less than 10 days, and no more than 2,600 mg per day for longer-term use. Higher cumulative doses of acetaminophen have been shown to predispose patients to serious adverse effects including liver damage, officials said.

Accentia is a Tampa, Fla., biopharmaceutical company focused on the development and commercialization of late-stage clinical products in the therapeutic areas of respiratory disease and oncology.

Accentia's growing specialty pharmaceutical business, Teamm Pharmaceuticals, Inc., has a portfolio of currently marketed products and a pipeline of additional products under development by third parties.

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