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 GW Pharmaceuticals, which has spent 20 years developing medicines
from cannabis, is hoping for a Food and Drug Administration (FDA)
green light by June 27, after winning support from an advisory panel
in April.
Some parents already use cannabis to help children with severe forms
of epilepsy, but such therapy is not monitored or licensed.
Scientists told a briefing in London on Thursday that new research
was unlocking the potential of certain cannabis compounds.
"We've learnt a huge amount about cannabis," said Valerie Curran,
head of the clinical psychopharmacology unit at University College
London. "It is still early, but it is proving a treasure chest of
potential medicines."
The researchers warned, however, that unregulated products that are
not tested for purity or consistency could expose patients to widely
varying doses and potential risks.
The rules governing cannabis use sparked a major row in Britain this
month when officials seized cannabis oil used by a 12-year-old boy,
Billy Caldwell, before eventually releasing it after he was admitted
to hospital due to seizures.
Once the FDA approves GW's drug Epidiolex and the drug is launched,
probably in early September, U.S. patients will for first time have
a licensed medicine to treat Dravet and Lennox-Gastaut syndromes,
two rare but severe forms of epilepsy.
CLINICAL TRIALS
Europeans will have to wait until the first quarter of 2019 for a
similar marketing approval decision from the European Medicines
Agency.
Epidiolex is a purified form of cannabidiol (CBD), a component of
cannabis that does not cause intoxication. It contains less than 0.1
percent of tetrahydrocannabinol (THC), the substance that makes
people high.
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Its success in clinical trials means analysts expect it to become a
$1 billion-plus seller and experts believe it will be a valuable new
weapon in controlling seizures.
"It gives us another medication when we've got very limited
medications that are actually helpful," said Helen Cross, a
consultant in pediatric neurology at Great Ormond Street Hospital
for Children.
But Cross, who worked on the GW clinical studies, noted the new
syrup treatment did not work for all patients.
GW already has one cannabis-based treatment for multiple sclerosis
approved outside the United States but Epidiolex is viewed as having
much greater medical and commercial potential.
Approval from the FDA, which is gate-keeper to the world's biggest
drugs market, will be a significant landmark - not just for GW but
also for other firms working on prescription drugs from cannabinoids,
the active chemicals found in marijuana.
"If it goes through, it will be a major milestone for the industry,"
said George Anastassov, CEO of U.S.-based Axim Biotechnologies,
which is developing cannabis-derived drugs for pain, bowel
conditions and other diseases.
The idea of using cannabis in medicine is not new. It was first used
in Egypt 3,000 years ago and Britain's Queen Victoria was also
prescribed tincture of cannabis.
But it is only recently that researchers have started to unpick the
complex mechanisms by which the different components in the
marijuana plant interact with the brain - sometimes in opposing
ways. While THC can induce paranoia, for example, CBD appears to
counter this effect.
(Editing by Alison Williams)
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