AEGiS-PRn: Drug with Active Marijuana Ingredient Available Through Medical Channels PRNewswireImportant note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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Drug with Active Marijuana Ingredient Available Through Medical Channels

PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Wednesday, 6 November 1996.


BUFFALO GROVE, Ill., Nov. 6 /PRNewswire/ -- Unimed Pharmaceuticals, Inc. (Nasdaq: UMED) today announced that, despite the passage of proposition 215 to make marijuana legal for medicinal purposes in California and a similar proposal in Arizona, a pure synthetic formulation of marijuana's active ingredient THC is available through established medical channels in the form of Marinol(R) (dronabinol), a prescription drug developed by Unimed Pharmaceuticals.

Based on findings from controlled clinical trials, Marinol is effective for the medicinal treatment of anorexia (loss of appetite) associated with weight loss in AIDS patients and to treat nausea and vomiting associated with certain cancer chemotherapy. Unlike marijuana, Marinol is administered in precise dosages as an oral capsule, and avoids health risks associated with smoking. There have been no controlled clinical studies to prove marijuana's safety and effectiveness.

Marinol is regulated by the U.S. Food and Drug Administration and the Drug Enforcement Administration. It is a Schedule II narcotic available only by prescription.

Marinol is a pure form of THC (delta-9-tetrahydrocannabinol) that has been synthesized in the laboratory to achieve precise control of dosage and strength. The prescription drug does not contain the more than 400 other substances found in marijuana smoke, including carcinogens and fungal spores that can cause chronic air flow obstruction of the pulmonary system. The health hazards of marijuana smoke are a special concern to the seriously ill, including AIDS and cancer patients and the elderly, who may be particularly susceptible to cardiopulmonary dysfunction and pneumonia.

In the pivotal AIDS clinical trial, dropout rates due to adverse events were similar in the Marinol group (18 percent) to those in the placebo group (15 percent). Side effects in this study were generally mild and were reversed by dosage reduction.

The most frequently reported adverse experiences involved the central nervous system (CNS) and were reported by 33 percent of Marinol patients. About 25 percent of patients reported a minor CNS event during the first two weeks and about four percent reported such an event each week for the next six weeks.

Marinol has been marketed since 1985 for cancer patients and since 1992 for AIDS patients. Other Marinol controlled clinical trials have been completed or are planned for potential uses in additional medical conditions.

Unimed Pharmaceuticals develops and markets niche pharmaceutical products for AIDS, endocrinology, urology and other therapeutic areas. The company also is growing through in-licensing niche marketed and late-stage development products.

CONTACT: Stephen M. Simes of Unimed Pharmaceuticals, 847-541-2525 or Karen Yancey of Sam Huff & Associates, 847-382-7404


Keywords: CLINICAL TRIAL; AIDS PATIENTS

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