Subj: US: DEA Proposes Reclassifying Marinol



Pubdate: Thu, 5 Nov 1998 



Source: Business Wire



Note: Business Wire is a press release service. As such, we are posting

this is an exception to our policy on carrying press releases.



DRUG ENFORCEMENT ADMINISTRATION PROPOSES RECLASSIFYING UNIMED'S SYNTHETIC

THC COMPOUND, MARINOL, TWO DAYS AFTER MARIJUANA REFERENDUMS PASS



Ruling Would Provide Increased Patient Access to Marinol



BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Nov. 5 1998-- The Drug Enforcement

Administration (DEA) today issued a ``Notice of Proposed Rulemaking'' in

which the DEA is proposing to reclassify Marinol(R) (dronabinol) from

Schedule II to Schedule III, a ruling that would provide increased patient

access to this FDA-approved synthetic THC compound. THC is an active

ingredient in marijuana. This proposed ruling comes on the heels of

voter-approved referendums in which residents of Arizona, Washington,

Colorado, Alaska, Nevada, Oregon and the District of Columbia supported

measures that endorse the use of medical marijuana.



Marinol, manufactured by Unimed Pharmaceuticals (NASDAQ:UMED - news), is an

oral medication that the Food and Drug Administration (FDA) has approved

for patients requiring appetite stimulation and for patients undergoing

chemotherapy that causes them to become nauseated. Marinol also is being

tested to assess its positive effects on behavior in people diagnosed with

Alzheimer's disease and other dementias.



Schedule II drugs are those that are recognized to have medical

indications, but have a high potential for abuse (examples include

morphine, cocaine, methadone and methamphetamine). Schedule III drugs have

accepted medical uses and a lesser potential for abuse (examples of drugs

in this class include codeine with aspirin or codeine with Tylenol(R)).



The DEA consulted extensively with the FDA before making this

recommendation. A study presented earlier this year at the College of

Problems of Drug Dependency's Annual Meeting showed that because Marinol

has a gradual onset of action, it has a very low potential for abuse. The

study also found that based on information gathered from law enforcement

officials in major cities across the U.S., there is no street market for

Marinol, and no evidence of any diversion of Marinol for sales as a street

drug.



``Adoption of the DEA proposal would represent a real pharmacoeconomic

benefit to both patients and to the healthcare system as a whole by

reducing the number of costly office visits by patients for whom Marinol is

a medical necessity,'' said Ronald Goode, Ph.D., president and CEO, Unimed

Pharmaceuticals. ``Furthermore, because the proposed change would allow

prescriptions for Marinol to be refilled up to three times per

prescription, patient convenience would be greatly enhanced.''



The public has until December 7, 1998 to file comments, objections and

requests for a hearing on the proposed reclassification. The DEA will then

rule on the proposed reclassification.



Unimed is an emerging, Chicago-area pharmaceutical company that develops

and markets life-enhancing pharmaceutical products to address unmet medical

needs in patients with chronic conditions. The company focuses on drugs

that have multiple indications and fall within the areas of endocrinology,

urology, HIV and other infectious diseases, hematology and oncology. Unimed

currently markets Marinol(R) as an appetite stimulant for people living

with HIV disease and as an antiemetic for people with cancer, Anadrol(R)-50

(oxymetholone) for the treatment of various anemias, and Maxaquin(R)

(lomefloxacin HCl) for both complicated and uncomplicated urinary tract

infections.