To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AXID AR, New Advance in Heartburn Prevention, Cleared for OTC Sale URL: http://www.pslgroup.com/dg/85BA.htm Doctor's Guide May 9, 1996
MADISON, N.J., May 9, 1996 -- AXID AR(R), the nonprescription version of the anti-ulcer medication AXID(R) (nizatidine), has received marketing clearance from the U.S. Food and Drug Administration (FDA), announced manufacturer Whitehall-Robins Healthcare, the consumer health care division of American Home Products Corp. (NYSE:AHP), today. AXID AR belongs to a relatively new class of over-the-counter medications known as acid reducers, which inhibit the release of acid in the stomach. In its prescription form, AXID is the fastest growing brand of oral H2-receptor antagonists in hospitals. Based on brand sales during the 52 week period prior to over-the-counter (OTC) status, this is the third largest prescription (Rx) to OTC switch in U.S. history. Effective Heartburn Prevention AXID AR will be available to consumers soon for the prevention of heartburn, acid indigestion, and sour stomach caused by food and beverages. "An over-the-counter acid reducer such as AXID AR will greatly benefit patients who suffer from heartburn. It not only prevents heartburn, it works quickly -- within 30 minutes -- and has an outstanding safety profile," says Thomas Brasitus, MD, gastroenterologist, Chicago. The efficacy of AXID AR was demonstrated in an extensive clinical research program of seven trials involving more than 1,400 individuals with a history of heartburn. These trials showed that one 75-mg does of AXID AR taken in as little as 30 minutes prior to a meal can effectively stop heartburn from occurring. Recommended dosage is one AXID AR tablet taken up to twice daily, one-half hour to one hour before consuming food and beverages that cause discomfort. Strong Physician Acceptance AXID AR also has an excellent safety profile, exhibiting a low overall frequency of adverse effects. The safety of prescription nizatidine has been well-established through worldwide clinical studies. It has been found to be well-tolerated by older adults and has a low potential to interact with other medications. More than 30 million prescriptions have been written for Axid during its eight-year history on the U.S. market. "The solid efficacy and safety profile of prescription nizatidine has made it a popular choice of physicians for treating gastroesophagal reflux disease," says Roger Berlin, MD, FACP, FACG, Senior Vice President, Scientific Affairs Worldwide,Whitehall-Robins Healthcare. "Nizatidine has a rapid onset of acid prevention and an excellent safety profile, characteristics that make it an outstanding over-the-counter heartburn medicine." H2-Blockers Creating Explosive Category Growth Last year, Americans spent nearly $1 billion to treat their heartburn with over-the-counter remedies, such as antacids. Now, the stomach remedy market has undergone radical transformation with the recent introduction of nonprescription H2-blockers. Industry analysts expect that introduction of the acid reducers AXID AR, Tagamet(R) HB, Pepcid AC(R), and Zantac(R) 75 will grow the category considerably. In the 11 months following market entry of the first OTC H2-blockers, dollar sales of the stomach remedy category increased by 46 percent versus one year ago. "Based on consumers' enthusiastic response to the introduction of over-the-counter acid reducers, there is enormous sales opportunity in the category from former prescription users, antacid users and new adopters," says Terrence L. Stecz, President, Whitehall-Robins Healthcare. "Based on the Whitehall-Robins Healthcare track record, we are confident that AXID AR will become a well-established brand in this explosive category." About Whitehall-Robins Healthcare Whitehall-Robins Healthcare is a leader in the research and development, manufacturing, and marketing of consumer health care products in areas including analgesics, cough, cold, allergy remedies, and family planning. Its parent company, American Home Products, is one of the world's largest research-based pharmaceutical and health care products companies and is a leading developer, manufacturer, and marketer of prescription drugs, over-the-counter medications, agricultural products, medical devices, animal health care, and food products. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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