A number of companies have made attempts to market prescription ulcer drugs as over-the-counter heartburn remedies, but Merck & Co. is the first one to succeed. On April 28, the Food & Drug Administration gave Merck approval to produce a lower-dose version of Pepcid (famotidine) as an OTC drug. Merck is now relying on Johnson & Johnson's expertise in the consumer health-care market to sell the new Pepcid AC acid controller version in a joint venture.
The two companies, trying to cash in on the $900-million antacid market, plan to price Pepcid AC competitively with antacids. They believe that Pepcid AC has an advantage over other heart burn remedies currently on the market. While current OTC antacids can relieve heartburn, Johnson & Johnson/Merck Consumer Pharmaceuticals' Pepcid AC can prevent it if taken before meals, the drug firms claim. Because Pepcid AC is an acid controller, it works at the source of heartburn by controlling the production of stomach acid rather than just neutralizing it. just one 1 O-mg tablet can prevent and relieve heartburn, a condition that affects 95 million Americans. The package insert for Pepcid AC will claim that it provides 70% relief and 75% prevention of heartburn.
The companies also claim that Pepcid AC is the safest heartburn remedy available in that it "has no significant interactions with other drugs." Pepcid AC has no warnings against use with prescription drugs, but pregnant and nursing women should consult their physicians before using the drug. Pepcid AC will be available over-the-counter in June in packages of 6, 12, and 18 tablets.
Many pharmacists believe that H sub 2 antagonists will do well as OTC drugs. "We found, by just casual observation and some retrospective study in patient populations, that more patients take the H sub 2 s prophylactically and to treat gastritis episodically than take it according to the package insert. They're not treating ulcers, usually, so much more of it is used for gastritis and for prophylaxis than it is used to treat true ulcer disease. So there's probably a real place for OTC use of the products," said Ray Marcrom, Pharm.D. and owner of Marcrom's Pharmacy, Manchester, Tenn.
Glaxo Wellcome PLC and Eli Lilly & Co. are also lying to create and market OTC forms of their Rx ulcer drugs, ranitidine and nizatidine, respectively.
SmithKline Beecham may be the next to win approval of an Rx-to-OTC switch. Since the FDA's Nonprescription Drugs & Gastrointestinal Drugs Advisory Committee has unanimously recommend that Tagamet HB (cimetidine) be approved for over-the-counter use in treating episodic heartburn, drug retailers may soon have this product on their shelves along with other OTCs. …