marijuana drug to return to market
By Associated Press May 16, 2006
- Seventeen years after it was withdrawn from U.S.
markets, a synthetic version of the active ingredient in
marijuana is going back on sale as a prescription
treatment for the vomiting and nausea that often
accompanies chemotherapy, its manufacturer said Tuesday.
Valeant Pharmaceuticals International hopes to begin
selling Cesamet in the next two to three weeks, company
president Wes Wheeler said.
The Costa Mesa, Calif. company received Food and
Drug Administration approval Monday to resume sales of
the drug, which it bought from Eli Lilly and Co. in
2004. Valeant currently sells the drug, also called
nabilone, in Canada.
received FDA approval for nabilone in 1985 but withdrew
it from the market in 1989, Wheeler said. Valeant, since
purchasing the drug, has revised its label and updated
its manufacturing process, he added.
The drug will compete with Marinol, made by
Belgium-based Solvay SA. Marinol, another synthetic
version of tetrahydrocannabinol, the active ingredient
in marijuana thatís more commonly known as THC. It also
received FDA approval in 1985.
Synthetic THC acts
on the brain like the THC in smoked marijuana, but
eliminates having to inhale the otherwise harmful smoke
contained in the illegal drug, Valeant said.
Cesamet is a
Schedule II drug, meaning it has a high potential for
abuse. The 1-milligram tablets are meant to be taken
twice daily before cancer patients undergo chemotherapy
and up to 48 hours following treatment. Side effects
include euphoria, drowsiness, vertigo and dry mouth.
The FDA last month
said it does not support the use of marijuana for