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Bayer
HealthCare submits cannabis spray for
Health Canada approval
Medical Update Memo
July 23, 2004
Summary
Bayer HealthCare has applied to Health Canada for
approval of a cannabis-based drug for the treatment of MS-related
pain and spasticity. The drug, which is called Sativex, consists
of various extracts from the cannabis plant. It is administered
via a spray into the mouth. The application is based on clinical
trials which took place in Britain in 2003. It typically takes
up to two years for Health Canada to review a drug application.
The MS Society is following the review process closely and
will provide more information when it is available.
Details
The Bayer HealthCare application to Health Canada for approval
of the cannabis-based spray is based on the results of a
clinical trial conducted in Great Britain last year which
was reported in The Lancet, Nov. 8, 2003.The British
study involved 657 people with MS, the largest clinical trial
of marijuana derivatives for the treatment of MS symptoms.
For 13 weeks, participants received either cannabis oil,
synthetic tetrahydrocannabinol (THC, the active ingredient
in marijuana) or inactive placebo. Following the treatment
period, those on active treatment had no objective improvement
in muscle spasticity as measured by a standardized scale.
However, treated participants reported improvements in walking
speed, another measure of spasticity, and symptoms of spasticity,
muscle spasms, sleep and pain.
Results
Data was obtained from 630 participants. There was no objective
evidence of a treatment effect on muscle spasticity, the
primary outcome of the study, using the standardized Ashworth
scale. The Ashworth scale, a 5-point scale, measures restriction
of movement in specific muscle groups and has been widely
used in prior studies of spasticity and its treatment, however,
it is known to measure only one aspect of spasticity. At
the end of the study, physicians asked participants to rate
their own sense of whether the agent they had taken had improved
their symptoms. Significantly more participants taking either
cannabis oil or THC reported subjective improvements in spasticity,
spasms, sleep and pain, but not tremor or bladder symptoms.
Among secondary outcomes studied was the
time it took to walk 10 metres. Walking times before and during
treatment were obtained from 278 participants; there was a
reduction in walking time by 12% in the group taking THC, compared
to a reduction of 4% in both the cannabis oil and placebo groups.
This difference was statistically significant. There was no
improvement on another mobility test.
There were serious adverse events in all
three groups: 20 in the placebo group, 18 in the THC group
and 12 in the cannabis oil group. More episodes of dizziness/
light-headedness, dry mouth, and gastrointestinal symptoms
occurred in the treatment groups.
The investigators also noted there were
fewer relapses in the treatment groups. Of the nine MS relapses
that occurred during the study period, seven were in the placebo
group and one each in the treatment groups. However, the study
was not designed to investigate impact on relapses so no conclusions
can be drawn from this finding.
Legal Status in Canada
Health Canada regulations allow people with certain illnesses
including MS to apply for permits to possess and/or grow
marijuana for personal medical purposes or to designate another
person to grow it for the person who has the permit. Health
Canada is also conducting a pilot project involving the use
of designated pharmacies to provide marijuana to permit holders.
All usages must be prescribed by physicians.
Details about how to apply for permits are available at www.hc-sc.gc.ca/hecs-sesc/ocma/index.htm Information
is also available by calling the Health Canada Cannabis Medical
Access Office toll-free: 1-866-337-7705 or 613 954-6540.
In July 2003, then federal Minister of Health Anne McLellan
announced an interim policy to allow Health Canada to provide
dried marijuana and/or marijuana seeds to individuals holding
federal permits. This decision was in response to complaints
by some permit holders that they were not able to access marijuana.
The product and seeds will come from Prairie Plant Systems
Inc., the company currently under contract with Health Canada
to produce marijuana for clinical trials. Details about how
to apply for dried marijuana and/or marijuana seeds are available
at www.hc-sc.gc.ca/hecs-sesc/ocma/index.htm Information
is also available by calling the Health Canada Cannabis Medical
Access Office toll-free: 1-866-337-7705 or 613 954-6540.
Some physician organizations have advised
their members not to prescribe marijuana because of the lack
of information about optimum prescribing and potential legal
issues. It is not yet clear if these recommendations will change
with respect to oral cannabis given the results of the Lancet study.
Individuals interested in the medical use
of marijuana should speak to their own physicians or contact
Health Canada.
ASK MS Information System Code: 1.4.1.20.z
National Research Department
National Communications & Government Relations Department
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Disclaimer
The Multiple Sclerosis Society of Canada is an independent,
voluntary health agency and does not approve, endorse or
recommend any specific product or therapy but provides information
to assist individuals in making their own decisions.
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