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Executive Summary

SEARLE's DAYPRO (OXAPROZIN) ONCE-A-DAY NSAID APPROVED OCT. 29 for acute and long-term treatment of osteoarthritis and rheumatoid arthritis. Searle said the nonsteroidal anti-inflammatory drug will be in pharmacies in "early 1993" and will be priced "competitively" with other NSAIDs. The recommended dose for Daypro is two 600 mg caplets once each day. Daypro is Searle's first NSAID. The company markets Cytotec (misoprostol) as a preventative for NSAID-induced gastric ulcers. FDA designated oxaprozin as a "1-S" drug, indicating a new molecular entity with a standard review period. The most common side effects associated with Daypro are gastrointestinal symptoms, such as nausea, and indigestion. Both side effects were reported in 8% of patients who participated in the oxaprozin clinical trials. Other side effects with an incidence above 3% are constipation, diarrhea and rash. The NDA for oxaprozin (18-841) has been pending at FDA since Aug. 10, 1982. Daypro received an "NDA Day" review by FDA on June 15-16 this year. Searle committed on Oct. 22 to seven Phase IV postmarketing studies for Daypro, FDA noted in its approval letter. The drug was developed by Wyeth-Ayerst, which licensed the marketing rights for the U.S., Canada, Puerto Rico and the Caribbean to Searle in December 1988. At the time, Searle said it had clinical trial results from more than 3,000 patients. Daypro is the first once-daily NSAID from the propionic acid derivative class, Searle noted, which includes the widely- prescribed NSAIDs Naprosyn (naproxen) from Syntex and Motrin (ibuprofen) from Upjohn. Pfizer's Feldene and generic versions of piroxicam also are once-a-day NSAIDs, but are from the oxicam family. Corporate Exec VP and President of North American Operations Joseph Curti, MD, said "approximately 60%" of the 70 mil. annual prescriptions for NSAIDS are for propionic acid derivatives.

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