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MARINOL RECEIVES APPROVAL AS THE FIRST MEDICATION FOR ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS

 COLUMBUS, Ohio, Dec. 23 /PRNewswire/ -- The Food and Drug Administration (FDA) yesterday approved a supplemental new drug application (SNDA) for Marinol (dronabinol) as treatment for anorexia associated with weight loss in patients with AIDS. Weight loss leading to debilitation is a common problem affecting people with AIDS. Patients with weight loss participating in clinical trials with Marinol experienced increased appetite after four weeks of treatment.
 Marinol is the first prescription medication approved by FDA to treat anorexia in patients with AIDS. The drug was first approved in 1985 as a treatment for nausea and vomiting associated with chemotherapy in patients who failed to respond to conventional antiemetic (anti-nausea) treatments.
 "If patients with AIDS have a good appetite and maintain good nutrition, they stand a better chance of retaining their body weight and fighting the disease," said Gerald Wojta, president of Roxane Laboratories. "Marinol is an important addition to AIDS treatment medications because it can improve the quality of life for many seriously ill people."
 Roxane Laboratories, Inc., of Columbus is the exclusive distributor of Marinol in the United States. Unimed, Inc., of Buffalo Grove, Ill., holds the new drug application (NDA) to Marinol.
 Marinol, which is only available in capsules, is a synthetic form of delta-9-tetrahydrocannabinol (THC), an active ingredient in marijuana. "Marinol is a pure form of THC synthesized in the laboratory, enabling precise control of dosage and strength," said Kirk Shepard, M.D., vice president, medical affairs, at Roxane Laboratories.
 Marinol is a Schedule II drug under the Controlled Substances Act, and is only available by a physician's prescription. For the AIDS indication, Marinol will be available in a prescription prepack bottle of 60 2.5 mg. capsules. The daily dosage is two capsules, one before lunch and one before dinner.
 Some patients may experience side effects that include drowsiness, dizziness, muddled thinking and brief coordination impairment. Patients should not drive, operate complex machinery, or engage in any activity requiring sound judgment and unimpaired coordination while receiving Marinol.
 Research for Marinol's effectiveness in treating anorexia in people with AIDS began in 1990. A randomized phase III national multi-center clinical trial compared Marinol to a placebo in a double blind study of 139 patients with AIDS.
 "To date, clinical trials reveal that Marinol does not appear to interfere with other AIDS treatment medications," said Shepard.
 Roxane Laboratories anticipates patients prescribed Marinol for its new AIDS indication will also receive reimbursement because Marinol is already reimbursed by Medicare, Medicaid and private insurance carriers as an anti-nausea medication for cancer patients.
 In addition, Roxane Laboratories has instituted a patient assistance program for indigent people with AIDS. "Our company's commitment is to work with AIDS patients, physicians, pharmacists and insurance carriers to ensure Marinol's availability to all patients who can benefit from the medication," said Wojta.
 Roxane Laboratories is a prescription specialty and generic pharmaceutical manufacturer located in Columbus. The company has a history of specializing in products that relieve pain and discomfort for the seriously ill. The company was particularly interested in developing the additional indication for Marinol use by patients with AIDS because it fits into this emphasis. Roxane is a subsidiary of Boehringer Ingelheim Corporation of Ridgefield, Conn., and is a member of the worldwide group of Boehringer Ingelheim companies.
 -0- 12/23/92
 /CONTACT: Ellena Friedman, 202-333-7400, or Kirk Shepard, M.D., 614-276-4000, both for Roxane Laboratories/


CO: Roxane Laboratories, Inc.; Boehringer Ingelheim Corporation ST: Ohio IN: MTC SU:

TW -- DC001 -- 9467 12/23/92 09:56 EST
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Date:Dec 23, 1992
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