FDA Requests Public Comments Regarding Marinol

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veggie

Registered: 07/25/04
Posts: 19,056

FDA Requests Public Comments Regarding Marinol

#5068111 - 12/15/05 05:14 PM (20 years, 9 months ago)

FDA Requests Public Comments Regarding Marinol
December 15, 2005 - norml.org

Rockville, MD: The US Food and Drug Administration (FDA), on behalf of the US Department of Health and Human Services (HHS), is seeking public comments concerning the abuse potential, medical usefulness, and availability of the prescription drug dronabinol (aka Marinol).

The FDA will forward the comments to members of the World Health Organization (WHO). WHO will meet in March to recommend whether certain"international restrictions" be placed on the drug in accordance with international treaty obligations.

Marinol (synthetic THC) is an FDA-approved Schedule III drug and is the only synthetic cannabinoid legally available by prescription in the United States. Physicians may prescribe Marinol for the treatment of cachexia (weight loss) in patients with AIDS and for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. However, patients prescribed the drug often report that it provides only limited symptomatic relief, particularly when compared to natural cannabis and its cannabinoids.

Currently, synthetic THC is classified internationally as a Schedule III drug under the 1971 Convention of Psychotropic Substances.

WHO will also be reviewing regulatory restrictions on several other controlled substances, including Ketamine, Khat, and GHB. Persons interested in submitting comments may do so electronically at:
www.fda .gov/dockets/ecomments

The public comment period ends on January 12, 2006.

For more information, please contact Allen St. Pierre, NORML Executive Director, at (202) 483-5500. Full text of NORML's report, "Marinol Versus Natural Cannabis: Pros, Cons and Options for Patients," is available at:
http://www.norml.org/index.cfm?Group_ID=6635

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