Johnson & Johnson-Merck has won the race to bring an H(2)-receptor antagonist to the over-the-counter (OTC) market. The joint pharmaceutical venture has received marketing approval for its 10-mg preparation of famotidine (Pepcid AC Acid Controller) from the Food and Drug Administration (FDA). The product is indicated for the treatment and prevention of heartburn and acid indigestion. Still available by prescription are 20- and 40-mg tablets of famotidine.
The manufacturer hopes to draw consumers who have been using popular antacid preparations. Product promotion, however, emphasizes that famotidine is not an antacid but works by blocking the secretion of gastric acid.
OTC famotidine (Pepcid) has been shown to prevent heartburn and acid indigestion when taken 1 hour before food or beverages that are expected to cause heartburn. In one efficacy study, the product prevented heartburn in 75% of cases, compared with 57% of cases with placebo. In a second study, preventive efficacy was 73% compared with 52% for placebo.
Clinical trials also assessed OTC famotidine for efficacy in relieving existing heartburn. More than 1700 men and women aged 18 to 81 years were treated at 58 clinical centers in the United States. The trials encompassed more than 2300 episodes of heartburn. In one study, complete relief occurred in 70% of episodes treated with 10 mg famotidine, compared with 41% of those treated with placebo. A second study showed 67% efficacy with famotidine, compared with 53% for placebo.
The manufacturer claims important safety advantages for OTC famotidine (Pepcid): No clinically significant interactions with other drugs have been reported, and the dose needed for efficacy is low. Furthermore, the safety profile of famotidine is well established from experience with prescription doses of the drug, which was first approved in 1986.
Pepcid AC Acid Controller is available as 10-mg tablets in packages of 6, 12, or 18. For relief of symptoms, a user should swallow one tablet with water (the tablet should not be chewed). For prevention of heartburn, one tablet should be taken 1 hour before consumption of food or drink that would be expected to produce heartburn. The maximum recommended dosage is two tablets a day.
The manufacturer is touting new easy-to-read labeling that uses icons, charts, and clearly written information to promote understanding of the product’s use. The labeling stresses that patients should consult a physician if they have difficulty swallowing or experience persistent abdominal pain, or if they have been taking the maximum daily dosage continuously for 2 weeks without relief.