Unimed Pharmaceuticals, a subsidiary of Solvay Pharmaceuticals and Marinol's manufacturer, stated on its website (accessed Apr. 13, 2006):
"MARINOL® is a unique prescription medicine that
relieves multiple symptoms. The United States Food and Drug
Administration (FDA) approved MARINOL® to treat nausea and vomiting
associated with cancer chemotherapy in patients who have failed to
respond adequately to conventional treatments.
The FDA also approved MARINOL® to treat appetite loss associated with
weight loss in people with AIDS. Health care professionals may
prescribe MARINOL® to help stimulate an HIV/AIDS patient’s appetite
so he or she will want to eat again.
MARINOL® is a synthetic version of a naturally occurring compound
known as delta-9-THC. Delta-9-THC stimulates appetite and reduces
nausea and vomiting by binding to special receptors found in the nervous
system.
MARINOL® is contraindicated in any patient who has a
history of hypersensitivity to any cannabinoid or sesame oil.
Patients should be warned not to drive, operate
machinery, or engage in hazardous activity until they establish they can
tolerate MARINOL® and perform such tasks safely.
A cannabinoid dose-related 'high' (easy laughing,
elation and heightened awareness) has been reported by patients
receiving MARINOL® in both the antiemetic (24%) and the lower dose
appetite stimulant clinical trials (8%). Other frequently reported
adverse events in MARINOL® clinical trials included abdominal pain,
nausea, vomiting, dizziness, euphoria, paranoid reaction, somnolence,
and thinking abnormal."
The Institute of Medicine published in its Mar. 1999 report titled "Marijuana and Medicine: Assessing the Science Base":
"Marinol (dronabinol) is the only cannabinoid with approval for marketing in the United
States....
Marinol is manufactured as a capsule
containing THC in sesame oil; it is taken orally. It was approved by
the FDA in 1985 for the treatment of nausea and vomiting associated
with cancer chemotherapy. In 1992, the FDA approved marketing of
dronabinol for the treatment of anorexia associated with weight loss in
patients with AIDS. The preclinical and clinical research on THC that
culminated in the FDA's 1985 approval was supported primarily from the
National Cancer Institute (NCI), whose research support goes back to
the 1970s....
Marinol is synthesized in the laboratory
rather than extracted from the plant. Its manufacture is complex and
expensive because of the numerous steps needed for purification. The
poor solubility of Marinol in aqueous solutions and its high first-pass
metabolism in the liver account for its poor bioavailability; only
10-20% of an oral dose reaches the systemic circulation.
The onset of action is slow; peak plasma
concentrations are not attained until two to four hours after dosing.
In contrast, inhaled marijuana is rapidly absorbed...
Marinol's most common adverse events are
associated with the central nervous system (CNS); anxiety, confusion,
depersonalization, dizziness, euphoria, dysphoria, somnolence, and
thinking abnormality."
The US Drug Enforcement Administration (DEA) stated in its online article "'Medical' Marijuana - The Facts", on its website (accessed Apr. 13, 2006):
A
pharmaceutical product, Marinol, is widely available through
prescription. It comes in the form of a pill and is also being studied
by researchers for suitability via other delivery methods, such as an
inhaler or patch. The active ingredient of Marinol is synthetic THC,
which has been found to relieve the nausea and vomiting associated with
chemotherapy for cancer patients and to assist with loss of appetite
with AIDS patients."
