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SYNTEX RECEIVES FDA CLEARANCE TO MARKET TORADOL TABLETS

 SYNTEX RECEIVES FDA CLEARANCE TO MARKET TORADOL TABLETS
 PALO ALTO, Calif., Dec. 20 /PRNewswire/ -- Syntex Corp. (NYSE: SYN) said today that the company has received permission from the United States Food and Drug Administration (FDA) to market Toradol(TM)- Oral (ketorolac tromethamine) in the United States for limited duration use, as needed, for the management of pain.
 Toradol, which was discovered and developed by Syntex Research, is a prescription analgesic that is an alternative to narcotics. It acts peripherally at the site of the pain. It does not act on the central nervous
system as do narcotic compounds. It does not have any known effects on opiate receptors and, hence, does not have opiatelike side-effects.
 Syntex Laboratories Inc. introduced Toradol IM, the intramuscular injectable form of the compound, in the United States in May 1990. The new oral formulation is expected to be widely available in pharmacies in March 1992.
 "We are proud to be able to bring another new important pain- reliever to the market in the United States," said Syntex Chairman and Chief Executive Officer Paul E. Freiman.
 "Toradol IM has been exceptionally well-accepted by physicians and patients since its introduction in the United States in May 1990. Now physicians will also have the opportunity to prescribe the oral formulation of a product they have come to depend on for pain relief in their patients," he said.
 Toradol Oral will be the only nonsteroidal anti-inflammatory (NSAI) analgesic available in both injectable and oral formulations in the United States.
 Freiman said that he expects Toradol Oral to make an important contribution to Syntex's future sales and results. Worldwide sales of ketorolac were $75 million in the company's 1991 fiscal year, which ended July 31, 1991.
 "The intramuscular form of Toradol has been widely accepted for the treatment of post-operative pain, and for trauma and other pain states that physicians see in the Emergency Room," said William T. Beaver, M.D., professor of Pharmacology and Anesthesia at Georgetown University School of Medicine.
 "Now, when a patient has responded well to intramuscular Toradol, and a physician believes that an oral analgesic is appropriate, the same drug will be available," Dr. Beaver added.
 Toradol Oral tablets are expected to be prescribed by primary care physicians; internists; emergency room physicians; Ob/Gyn, orthopedic and general surgeons; and other physicians who treat patients for pain. Syntex expects to co-market Toradol Oral during its initial years on the market. The company expects to have an agreement signed in the near future with a marketing partner who will call on certain physicians on whom Syntex does not generally call.
 The analgesic efficacy of intramuscularly and orally administered Toradol was investigated in two postoperative pain models: general surgery (orthopedic, gynecological and abdominal) and oral surgery (removal of impacted third molars). Pain relief was comparable following either intramuscular or oral administration.
 Patients who received oral doses of Toradol had statistically significantly better pain relief at two hours and beyond and fewer side-effects than patients who received acetaminophen with codeine. The onset of analgesic action and peak pain relief were similar for Toradol and the narcotics studied; however, the analgesic effect of Toradol lasted longer.
 In clinical trials, the most frequent side effects were those associated with nonsteroidal anti-inflammatory drugs (NSAIDS), including gastrointestinal effects. The most serious risks associated with Toradol were gastrointestinal, renal and hypersensitivity to the drug. Toradol Oral is not recommended for long-term use in patients with chronic painful conditions, as the incidence of adverse gastrointestinal events increases with prolonged use. However, adverse reaction rates from short-term use of NSAIDS are generally 1/10 to 1/2 the rates associated with chronic usage; that is also true of Toradol.
 The total U.S. market for oral analgesics, estimated by independent market analysts to be approximately $1.9 billion dollars, consists primarily of oral narcotics and NSAIDs. Based on the demonstrated efficacy of Toradol Oral, it is expected that Toradol will compete in the oral narcotics segment of the prescription analgesic market.
 Syntex is a multinational healthcare company that discovers, develops, manufactures and markets prescription medicines that treat serious human diseases. Syntex also develops, manufactures and markets animal pharmaceutical products and medical diagnostic systems.
 -0- 12/20/91
 /CONTACT: Linda Thomas, 415-852-1321; or Kathleen Gary, 415-855-5924, both of Syntex Corp./
 (SYN) CO: Syntex Corporation ST: California IN: MTC SU:


RM -- SJ007 -- 4604 12/20/91 18:18 EST
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Date:Dec 20, 1991
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