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March 17, 1993

Dronabinol Approved for Use in Anorexia Associated With Weight Loss in Patients with AIDS

Author Affiliations

Associate Commissioner for Health Affairs

JAMA. 1993;269(11):1361. doi:10.1001/jama.1993.03500110025009

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The FDA has approved a supplemental new drug application for dronabinol for anorexia associated with weight loss in patients with acquired immunodeficiency syndrome (AIDS). The new indication is based on clinical studies involving patients with AIDS, in which the appetite-stimulation effect of dronabinol was sustained for up to 5 months. Dronabinol is manufactured by Unimed Inc, of Buffalo Grove, Ill, under the trade name Marinol. The drug is distributed by Roxane Laboratories Inc of Columbus, Ohio.

Dronabinol is chemically synthesized Δ9-tetrahydrocannabinol, the principal active ingredient in marijuana. Dronabinol was approved initially in 1985 as an antiemetic for treatment of nausea and vomiting associated with cancer chemotherapy (JAMA. 1986;256:817). In January 1991, dronabinol was granted Orphan Drug status for appetite stimulation in patients with AIDS-related weight loss. Orphan Drug status entitles a sponsor to financial incentives for developing drug products for diseases or conditions affecting fewer than 200 000