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

J&J's SUPROL (SUPROFEN) IS FIRST NSAID TO CLEAR FDA IN ALMOST FOUR YEARS; PRODUCT IS CANDIDATE TO FILL MARKETING HOLE LEFT BY ZOMAX WITHDRAWAL

Executive Summary

J&J's Suprol (suprofen) approval marks the first nonsteroidal anti-inflamatory to clear FDA in almost four years. The most recent NSAIDs, Lilly's Oraflex (benoxaprofen) and Pfizer's Feldene (piroxicam), were approved in April 1982. Suprol was approved Dec. 24 after a seven-year FDA review. Labeling describes the agent as a non-narcotic "peripherally acting analgesic" indicated for "the relief of mild to moderate pain [and] the treatment of primary dysmenorrhea." Suprol becomes a candidate to fill some of the gap left by the company's earlier NSAID analgesic Zomax (zomepirac sodium), which was withdrawn from the market in 1983 because of reports of an unacceptably high rate of fatal allergic reactions. At the time of withdrawal, Zomax was annualizing at nearly $100 mil. Zomax was indicated for "the relief of mild to moderately severe pain." Both Zomax and Suprol are described by labeling as NSAIDs "developed as an analgesic" that also possess "antipyretic properties." Labeled warnings for the two products state that "peptic ulceration and/or gastrointestinal bleeding have been reported" in patients receiving the drug. Suprol's warning notes that these events have been observed in 1% of the population receiving doses of 800-1600 mg/day. In controlled clinical trials with Suprol in over 800 patients who received the drug for one week or more, of whom 537 were treated for at least three months, and 103 for at least one year, "gastrointestinal symptoms were the most frequently reported adverse experiences, ranging from 10-20% in Suprol long-term studies," the labeling states. The most frequent adverse reaction "was nausea which occurred in about 15% of the patients." J&J plans to launch the drug the week of Jan. 13. The price to whslrs. is $29.50 for a bottle of 100, 200 mg capsules. McNeil, which has most of the marketing responsibility, will promote the drug in the primary care area. Ortho will be responsible for the OB/GYN marketing segment. According to FDA's approval letter, J&J is committed to post-marketing "bioavailability studies in geriatric, renal and hepatic disease patients to assess the pharmacokinetics of suprofen and its metabolites." The letter adds that the firm must "conduct plasma protein binding and binding interaction studies of suprofen with aspirin and acetaminophen at 37 degrees C, as well as a study of the effect of tolbutamide, warfarin and phenytoin on the protein binding of suprofen." The overall NSAID track record in adverse reactions over the last five years has been responsible for FDA's unofficial moratorium on NSAID approvals. The agency was criticized for approving several products, including Zomax, which were subsequently removed from the market. Other examples include Lilly's Oraflex U.S. withdrawal and Merck's suspension of sales of Indosmos in Europe in 1983, and Warner-Lambert's recent suspension of sales in Europe of isoxicam (Maxicam). The review time of Suprol may also have been affected by J&J's aggressiveness in disputing FDA's DESI-ineffective decision on Parafon-Forte, and pursuing a legal challenge to OTC ibuprofen. According to an FDA memo of a June 19 meeting between FDA officials and J&J CEO James Burke, Office of Drug Research and Review Program Management Deputy Director Richard Terselic told J&J that the company's "pursuance of the defense of Parafon-Forte was an example . . . of a highly costly and limited success potential advocacy by J&J that cut into the time available for review of their NDAs." Burke had specifically asked at the meeting "why there was so much delay in getting products approved" in the Oncology and Radiopharmaceutical Div. -- which handles NSAIDs and pain products as well as cancer and in vivo diagnostics. FDAer John Harter, MD, cited J&J's INDs/NDAs, challenge to OTC ibuprofen, and Parafon-Forte as taking "a more than normal percentage of the total time of his group," according to the memo ("The Pink Sheet" July 15, T&G-3).

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

LL035386

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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