Prilosec 24-Hour Acid Control Would Be Unique To OTC Category
This article was originally published in The Tan Sheet
Once-a-day dosing of heartburn remedy Prilosec could be highlighted by AstraZeneca/Proctor & Gamble as a competitive advantage over other OTC stomach therapies if an Rx-to-OTC switch of the proton pump inhibitor were approved by FDA.
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AstraZeneca dedicated $62.2 mil. to DTC advertising for Rx Prilosec (omeprazole) in the first six months of 2000, according to measured media spending data from Competitive Media Reporting.
Self-treatment of nighttime heartburn with OTC drugs will protect only about one-third of sufferers from potentially serious medical conditions, Donald Castell, MD, The Graduate Hospital, Philadelphia, opined Aug. 24.
FDA's Nonprescription and Gastrointestinal Drugs Advisory Committees will meet jointly Oct. 20 to consider AstraZeneca's NDA 21-229 to switch its blockbuster drug Prilosec (omeprazole) OTC; the nonprescription product would be distributed by Procter & Gamble. Proposed indications the committees will review are: "To relieve heartburn, acid indigestion and sour stomach" and "To prevent heartburn, acid indigestion and sour stomach brought on by consuming foods and beverages or associated with events such as stress, hectic lifestyle, lying down or exercise." On Oct. 19, NDAC will consider the safety of phenylpropanolamine, giving attention to a CHPA-sponsored Yale study on the risk of hemorrhagic stroke and PPA (1"The Tan Sheet" May 29, p. 11)