June 20, 2003 -- The Food and Drug Administration (FDA) today announced the approval of Prilosec OTC (omeprazole), the first over-the-counter treatment for frequent heartburn.
"Today's approval of over-the-counter Prilosec is yet another example of the important role FDA serves in improving access to safe and effective treatments for conditions that people can treat themselves," said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "As has been the case for many other over-the-counter switches, the availability of Prilosec OTC will help reduce costs and expand the availability of treatment options for millions of Americans."
Unlike the two classes of currently marketed over-the-counter heartburn treatments, antacids and acid reducers, Prilosec OTC is indicated for the treatment of heartburn that occurs two or more days per week (frequent heartburn). It stops acid production at its source in the stomach. Prescription Prilosec is currently widely prescribed for frequent heartburn and other related, but more serious, problems that need the care of a physician. Antacids and acid reducers, which have long been available over-the-counter, are used for the relief of acute heartburn symptoms. Acid reducers are additionally used for the prevention of meal-induced heartburn.
According to the American College of Gastroenterology, over 60 million Americans experience heartburn at least once a month and some studies have suggested 15 million Americans experience heartburn daily. Heartburn occurs when stomach contents containing acid back up and out of the stomach into the esophagus causing a burning sensation in the chest or throat.
Prilosec OTC is a delayed-release 20mg tablet that must be taken before eating once a day, every day for 14 days. Prilosec OTC may take one to four days for full effect, although some consumers may get complete relief of symptoms within 24 hours.
Prilosec OTC is not for people who have heartburn infrequently, one episode of heartburn a week or less, or for those who want immediate relief of heartburn. If frequent heartburn returns soon after 14 days of Prilosec OTC treatment, consumers should contact their healthcare providers. Consumers should not take a 14-day course of Prilosec OTC more often than every four months for frequent heartburn unless directed by a doctor.
FDA based its approval of Prilosec OTC on the results of various studies, including two clinical studies. These two clinical studies demonstrated that Prilosec OTC was effective in increasing the proportion of patients with no heartburn over 24 hours and that the effectiveness of Prilosec OTC increases from Day 1 to Day 14.
Before using Prilosec OTC or any medicine, FDA advises consumers to read the package label for complete information about the product's uses, warnings, and directions.
Although side effects from Prilosec OTC are not common, they can occur and may include: headache, diarrhea, constipation, upset stomach, vomiting, stomach pain, cough, cold symptoms, dizziness and rash. Prescription Prilosec (omeprazole), first approved by FDA in 1989, will remain available as a prescription treatment for diseases that require diagnosis and supervision by a doctor, such as Gastroesophageal Reflux Disease (GERD), inflammation of the esophagus (esophagitis) and ulcers.
Because of the safety studies performed by the manufacturer of Prilosec OTC, this product will have three years of over-the-counter exclusivity. Generic versions of the prescription product will not be able to market an OTC version until the marketing exclusivity has expired.
AstraZeneca LP of Wilmington, Del., and Procter and Gamble of Cincinnati,
Ohio, are the sponsors of the approved New Drug Application (NDA) for Prilosec
For additional information, please visit the GERD Center.
Source: FDA Talkpaper #P03-48, June 20, 2003