Answers
12/23/1992

<TITLE>FDA APPROVES NEW INDICATION FOR DRONABINOL</TITLE>
<PRE>

T92-71                                                     Monica Revelle
Dec. 23, 1992                                              (301) 443-4177

                 FDA APPROVES NEW INDICATION FOR DRONABINOL

    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 a 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, N.Y., under the trade      
name Marinol.  The drug is comarketed with Roxane Laboratories, Inc., of      
Columbus, Ohio.
</PRE>