Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

PHARMACIA’s DIPENTUM (OLSALAZINE) IS "APPROVABLE"

Executive Summary

PHARMACIA's DIPENTUM (OLSALAZINE) IS "APPROVABLE" on May 4. The company is seeking approval of the second-generation sulfasalazine (5-ASA) product for use in the treatment, the maintenance of remission and the prevention of reocurrence of ulcerative colitis. The Dipentum NDA was filed in late 1987. As of July 13, Pharmacia had not yet received final approval for the product. Pharmacia's 25-person U.S. sales force already markets a 5-ASA drug for ulcerative colitis, Azulfidine (sulfasalazine), which has been available since 1941 for the treatment of inflammatory bowel diseases. An NDA for Azulfidine EN-tabs for the treatment of rheumatoid arthritis is pending at FDA. Dipentum cleared FDA's Gastrointestinal Drugs Advisory Committee in September 1988 ("The Pink Sheet" Sept. 19, 1988, T&G-1). The committee voted six to three (with one abstention) in favor of recommending the product's approval for acute treatment of ulcerative colitis, and voted nine to one in favor of the relapse prevention indication. One committee member suggested that Dipentum's primary advantage over other sulfasalazine products is the absence of sulfapyridine, which may cause intolerance to the drug in some patients and reduce sperm counts in some male patients. At the time of the advisory committee meeting, Pharmacia had completed nine controlled studies and four open-label studies (as part of a 21-study clinical program). Nearly 1,400 patients had received olsalazine at that point. Of the nine controlled studies, seven were in acute disease and two were for relapse prevention. Five of the seven acute disease trials compared olsalazine to placebo, while the other two compared olsalazine to sulfasalazine. Committee members expressed concern with the relative efficacy of olsalazine -- due to the small studies of short duration presented by Pharmacia -- and a 36% incidence of diarrhea during clinical trials. One member recommended that olsalazine labeling for acute treatment carry "warnings against diarrhea with introduction of therapy." It was also suggested that approval be granted to Pharmacia on condition that the company conduct a "comprehensive and relative dosing study (to) interpret minimal and maximal dosing." FDA Division of Gastrointestinal and Coagulation Drugs Director Stephen Fredd, MD, agreed that a Phase IV study would help FDA determine the labeling for diarrhea management. Pharmacia said it is currently in discussions "with prominent gastroenterologists and FDA about what the appropriate studies will be after the drug is launched."

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS017760

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