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aaiPharma Announces FDA Approval of Darvocet A500(TM).

aaiPharma Inc. announced that it received confirmation today of U.S. Food and Drug Administration (FDA) approval of Darvocet A500(TM) (propoxyphene napsylate and acetaminophen) for the treatment of mild to moderate pain. Darvocet A500(TM) is the only propoxyphene napsylate/acetaminophen combination product currently FDA approved that contains a lower (500 mg) dose of acetaminophen combined with 100 mg of propoxyphene napsylate, the same dose of propoxyphene napsylate found in Darvocet-N(R) 100. This new product will provide patients a unique Darvocet(TM) formulation with the safety benefits of less acetaminophen and the full power of propoxyphene.

"Darvocet A500(TM) will provide an important alternative for health care providers concerned about high acetaminophen intake in patients suffering from mild-to-moderate pain," commented Dr. Philip S. Tabbiner, President and CEO of aaiPharma. "Because the FDA has established a 4,000 mg maximum daily dose of acetaminophen for adults and physicians are concerned about patients who self medicate using over-the-counter products, we believe there is a significant market opportunity for this dose combination which contains less acetaminophen while retaining the full power of propoxyphene napsylate. This product is a clear illustration of our strategy to bring to market line extensions that make established products safer for patients and patient management easier for physicians."

As previously announced, aaiPharma acquired the product from Athlon Pharmaceuticals. The Company is preparing for an immediate launch to the trade followed by a national launch of Darvocet A500(TM) in October.

Darvocet A500(TM) contains 100 mg of propoxyphene napsylate and 500 mg of acetaminophen compared to the Darvocet-N(R) 100 presentation, which contains 100 mg of propoxyphene and 650 mg of acetaminophen. The Darvocet-N(R) 100 presentation, branded and generic, currently accounts for 95% of the more than $500 million total propoxyphene market, according to Verispan data.

About aaiPharma

aaiPharma Inc. is a leading, science-based specialty pharmaceutical company with corporate headquarters in Wilmington, North Carolina. With more than 23 years of drug development expertise and a proven sales and marketing track record, the Company is focused on acquiring, improving and marketing well-known, branded medicines in pain management, critical care and gastroenterology. In addition to its branded product portfolio and robust pipeline, aaiPharma continues to offer comprehensive drug development services to the pharmaceutical, biotechnology, generic and device industries through its services division, AAI Development Services. For more information, please visit aaiPharma's website at

Forward Looking Statements

Information in this press release contains certain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, including statements concerning the future medical and commercial significance of, and the market opportunity for, the approved Darvocet A500(TM) product, the uniqueness of the product and its dose combination, the future use of aaiPharma's sales force to promote the product, and the future development (including through the use of our research and drug development capabilities), regulatory approval, commercialization and growth of products in the Company's pipeline and of its product portfolio. The "forward-looking statements" herein involve risks and uncertainties that could cause actual results to differ materially, including, without limitation, risks and uncertainties pertaining aaiPharma's ability to timely and successfully develop, improve, obtain timely regulatory approval for, and profitably sell pharmaceutical products (including Darvocet-A500(TM)); to obtain, use, enforce, defend and license valid and commercially valuable patents; to obtain and enforce existing and future contracts with major pharmaceutical companies for significant royalties and other consideration; and on the commercial success of the contemplated products. Additional factors that may cause the actual results to differ materially are discussed in aaiPharma's recent filings with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K filed on March 28, 2003, including its Exhibit 99.1 and other exhibits; its Forms 10-Q filed on May 15, 2003 and August 14, 2003, its Form 8-Ks; and its other periodic filings.

Darvocet(TM) is a trademark and Darvocet-N(R) and Darvon(R) are registered trademarks owned by aaiPharma Inc.

CONTACT: media, Andrea L. Johnston, Vice President, Corporate Communications, +1-910-254-7340, or investors, James B. Sloan, Jr., Senior Vice President, Corporate Finance, +1-910-254-7690, both of aaiPharma Inc.

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Publication:PR Newswire
Geographic Code:1USA
Date:Sep 11, 2003
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