COMPANY PLANS EXPERIMENTAL AIDS DRUG GIVEAWAY.Byline: Associated Press Associated Press: see news agency. Associated Press (AP) Cooperative news agency, the oldest and largest in the U.S. and long the largest in the world. Agouron Pharmaceuticals Inc. plans to give away its experimental AIDS drug, Viracept, to hundreds of patients who have exhausted other treatments, the company said Monday. Viracept is a member of a family of protease inhibitor protease inhibitor (prō`tē-ās'), any of a class of drugs that interfere with replication of the AIDS virus (HIV), by blocking an enzyme (protease) necessary in the late stages of its reproduction. drugs that, when used in combination with other drugs, can bring the virus down to undetectable levels in the blood of some patients. It will be offered to people who have stopped using three commercially available protease inhibitors Protease Inhibitors Definition A protease inhibitor is a type of drug that cripples the enzyme protease. An enzyme is a substance that triggers chemical reactions in the body. because of adverse reactions adverse reactions, n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. , intolerable side effects Side effects Effects of a proposed project on other parts of the firm. or because they haven't worked, La Jolla La Jolla (lə hoi`yə), on the Pacific Ocean, S Calif., an uninc. district within the confines of San Diego; founded 1869. The beautiful ocean beaches, in particular La Jolla shores and Black's Beach, and sea-washed caves attract visitors and , Calif.-based Agouron said. The drug hasn't been approved by the U.S. Food and Drug Administration. But the giveaway announced Monday is an effort by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. to make experimental drugs available early to patients who have no alternatives, the company said in a statement. Spokeswoman Joy Schmitt said enough drugs will be available to serve roughly 2,000 patients. The program is similar to those set up by the makers of the three commercially available protease inhibitors before those drugs were approved. Agouron differs from the others because Viracept would be its first commercial product. The others, Abbott Laboratories, Hoffmann-LaRoche Inc. and Merck & Co., are all major drug manufacturers. Agouron said the safety of the drug has been tested on more than 500 people and that the most commonly reported side effects were diarrhea, headache and fatigue. More tests are being conducted, and Agouron officials said they expect to seek approval for the drug from the FDA early next year. The giveaway will end if the drug is approved for sale. Schmitt said those who can't afford it at that time will be transferred to the company's patient assistance program, which will help them in paying the cost and will guarantee they receive it for at least a month. Details of that program remain to be worked out, but Schmitt declined to offer a guarantee that all patients who enroll in the expanded access program will keep getting the drug indefinitely - even if they can't pay. |
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