FDA Approves New Indication For Dronabinol

Date: December 23, 1992
Source: Food and Drug Administration (FDA)

FDA has received inquiries about the recent approval of dronabinol for the treatment of anorexia associated with weight loss in patients with AIDS. The following can be used to answer questions.

Dronabinol is synthetic form of delta-9-tetrahydrocannabinol (THC), an active ingredient in marijuana that was first approved in 1985 for nausea and vomiting associated with cancer chemotherapy.

More recently, anecdotal reports by people with AIDS on the benefits of marijuana use prompted clinical studies that showed the use of dronabinol by AIDS patients was associated with a statistically significant improvement in appetite.

In January 1991, dronabinol received orphan drug designation for appetite stimulation in patients with AIDS-related weight loss. Orphan drug designation entitles a sponsor to financial incentives following development and approval. A drug for diseases or conditions affecting fewer than 200,000 people in the United States is eligible for such a designation.

Dronabinol is manufactured by Unimed, Buffalo Grove, Ill., under the trade name Marinol. The drug is co-marketed with Roxane Laboratories, Inc. of Columbus, Ohio.