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Executive Summary

Hoechst-Roussel Trental is a 1-A (new chemical entity representing a major therapeutic gain) for the treatment of intermittent claudication. The drug was approved by FDA on Aug. 30. According to FDA-approved labeling, Trental (pentoxifylline) is indicated "for the treatment of intermittent claudication on the basis of chronic occlusive arterial disease of the limbs." The labeling states that the drug "can improve functions and symptoms, but is not intended to replace more definitive therapy such as surgical bypass for removal of arterial obstructions when treating peripheral vascular disease." The company's price to whslrs. is $24.20 for bottles of 100, 400 mg controlled-release tablets. The whslr. price represents a 17% discount off the company's list price of $29.15. Hoechst will begin shipping the product on Sept. 17, and hopes to achieve 90% drugstore distribution within four weeks of the launch. The Trental approval follows several other drug approvals for Hoechst in the last few years. Hoechst's third generation antibiotic Claforan was approved in 1981, followed by Loprox, a topical antifungal, and Streptase, an antithrombolytic, in 1982. The firm's oral antidiabetic DiaBeta cleared FDA last May. Hoechst's antidepressant Merital has had approvable status since April. Hoechst's NDA for Trental was originally submitted in May 1981. FDA's Cardio-Renal Drugs Advisory Cmte. reviewed the drug shortly thereafter (August 1981), recommending approval for the intermittent claudication indication.Final FDA approval followed three years later. Trental was first marketed by Hoechst outside the U.S. in 1972. The firm currently markets the drug in Germany, Japan, and U.K., and over 50 other foreign countries. As a condition of approval FDA is requiring Hoechst to conduct post marketing studies to determine the lowest effective dose for the drug. FDA said that testing was needed because side effects appearing in the firm's trials, including nausea, dizziness and headache, appeared to be dose related. The NDA only included efficacy testing of one dose, 1200 mg daily. Hoechst is including with its introduction of the drug a patient education program which the company says is designed to help the patient understand the claudication condition and include other facets of therapy with the drug regimen. The program consists of four booklets, which the patient will receive in a timed sequence, intended to reinforce compliance with a "total regimen." The patient will initially receive a booklet from the prescribing physician providing an overview of the condition and its therapy, followed by booklets providing instructions for an exercise/walking program, guidelines for a low-fat, low-cholesterol diet, and tips on stopping smoking, which the patient will receive in timed intervals by mail.

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