June 21, 2002
Joint Meeting of the Nonprescription Drugs Advisory Committee with the Gastrointestinal DrugsAdvisory Committees
Food and Drug Administration
Center for Drug Evaluation and Research
Holiday Inn, Bethesda
NDA 21-229 Prilosec (20 mg for 14 days ) for OTC use
(NDA 21-229, omeprazole magnesium, Astra Zeneca LP/Procter and Gamble)
Currently, there are two classes of drugs, antacids and acid reducers (histamine-2 receptor antagonists), available in the over-the-counter (OTC) market to treat heartburn. Both, antacids and acid reducers, are indicated for the treatment of acute heartburn symptoms. The acid reducers have an additional claim for the prevention of meal induced heartburn symptoms if ingested at specified times prior to a meal. Omeprazole, a proton-pump inhibitor, is currently indicated for prescription use for the treatment of duodenal and gastric ulcer, symptomatic GERD, erosive esophagitis, and pathological hypersecretory conditions. Clinical efficacy studies with omeprazole have established that it is not effective in treating acute symptomatic heartburn and does not prevent episodic meal induced heartburn (when taken shortly before a meal). Studies have established that omeprazole is most effective in preventing heartburn when taken repetitively on a daily basis. The sponsor is seeking to market Prilosec 1 OTC for the 24-hour prevention of heartburn in the population of frequent heartburn sufferers (defined as suffering heartburn on two or more days per week). The sponsor has proposed a 14-day daily treatment course.
Frequent heartburn may also be the presentation for consumers with serious underlying conditions (e.g. GERD +/- erosive esophagitis). The current direct-to-consumer marketing for prescription Prilosec is directed toward consumers with heartburn symptoms occurring as frequently as two or more days a week and encourages them to contact their physician. For Prilosec 1, the Drug Facts label states that it should be used for frequent heartburn and only for those who suffer heartburn two or more days per week. Thus, the same symptomatic heartburn population will be directed to either use Prilosec 1 or prescription Prilosec.
If Prilosec is available OTC, the sponsor acknowledges that some consumers with GERD +/- erosive esophagitis will choose to use Prilosec 1. Is it acceptable that some patients with GERD +/- erosive esophagitis self-treat with OTC medication? Please explain under what circumstances this is acceptable or not acceptable.
Has the sponsor demonstrated that consumers with heartburn can adequately self-select use of Prilosec 1? When answering this question consider the data provided in the labeling comprehension studies and actual use study for use by individuals:
In the actual use study, the sponsor provides information on the behavior of consumers who have a reoccurrence of heartburn symptoms after completing the 14-day course of therapy. Did consumers who had a reoccurrence of heartburn symptoms respond appropriately? When answering this question comment on the likelihood that consumers will seek advice from a health care professional (HCP) or the likelihood of the consumer using the product again without the advice of a HCP. Describe any other data in the submission that support your answer.
Has the sponsor provided sufficient information to support the approval of Prilosec 1 for the prevention of frequent heartburn? Please describe the data that influenced your decision.
If the committee recommends approval:
If the committee does not recommend approval: