World's first cannabis-based prescription drug could soon hit U.S pharmacy shelves
A British company is conducting landmark trials which could see medicines derived from or inspired by the cannabis plant itself making their way to American pharmacy shelves.
GW Pharma is in advanced clinical trials for the world's first pharmaceutical developed from raw marijuana instead of synthetic equivalents – a mouth spray it hopes to market in the US as a treatment for cancer pain. The firm hopes to receive US government approval by the end of next year.
Marijuana's two best known components go into the mouth spray which may become available in every pharmacy
The trials come a quarter of a century
after the US Food and Drug Administration (FDA) approved the first
prescription drugs based on the main psychoactive ingredient in
Sativex contains marijuana's two best
known components – delta 9-THC and cannabidiol – and has already been
approved in Canada, New Zealand and eight European countries for
relieving muscle spasms associated with multiple sclerosis.
FDA approval would represent an
important milestone in the United States' often uneasy relationship with
marijuana, which 16 states and Washington DC already allow people to
use legally with doctors' recommendations.
The US Drug Enforcement Administration
categorises pot as a dangerous drug with no medical value, but the
availability of a chemically similar prescription drug could increase
pressure on the government to revisit its position and encourage other
drug companies to follow in GW Pharma's footsteps.
The drug is to be marketed in America as a treatment for cancer pain
Possessing marijuana is still illegal
in the UK but about a decade ago GW Pharma's founder, Dr Geoffrey Guy,
received permission to grow it to develop a prescription drug.
Dr Guy proposed the idea at a
scientific conference that heard anecdotal evidence that pot provides
relief to multiple sclerosis patients, and the British government
welcomed it as a potential way “to draw a clear line between
recreational and medicinal use”, company spokesman Mark Rogerson said.
Doctors and multiple sclerosis patients are cautiously optimistic about Sativex.
FDA approval of the spray would be a huge milestone in the nation's often uneasy relationship with marijuana
National Multiple Sclerosis Society has not endorsed marijuana use by
patients, but the organization is sponsoring a study by a University of
California, Davis neurologist to determine how smoking marijuana
compares to Marinol in addressing painful muscle spasms.
cannabinoids and marijuana will, eventually, likely be part of the
clinician's armamentarium, if they are shown to be clinically
beneficial,' said Timothy Coetzee, the society's chief research officer.
'The big unknown in my mind is whether they are clearly beneficial.'
In addition to exploring new applications for Sativex, the company is developing drugs with different cannabis formulations.
Opponents and supporters of crude
marijuana's effectiveness generally agree that more research is needed,
while marijuana advocates fear that the government will use any new
prescription products to justify a continued prohibition on marijuana