Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

SEARLE’s DAYPRO (OXAPROZIN) ONCE-A-DAY NSAID APPROVED OCT. 29

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1134044

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel