* UK/Canada: Sativex gets approval in Canada for the
treatment of neuropathic pain in multiple sclerosis
* Science: THC effective in appetite and weight loss in severe
lung disease (COPD)
* Science/Economy: THC inhaler offers safe and rapid delivery
1.
UK/Canada: Sativex gets approval in Canada for the treatment
of neuropathic pain in multiple sclerosis
On 19 April the British company GW Pharmaceuticals
announced that their cannabis extract Sativex has been granted
regulatory approval in Canada for the symptomatic relief of
neuropathic pain in multiple sclerosis. According to a statement
by the company the drug is likely to be launched in May and the
price would only be announced shortly before launch.
Dr. Geoffrey Guy, Executive Chairman of the company, said,
"We are delighted that Sativex has received regulatory approval
in Canada. This event marks the world’s first approval of a
cannabis derived medicine. This first regulatory approval has
been obtained by GW in just over six years since the
Company’s development programme commenced, a highly
significant achievement. We are now working with our Canadian
marketing partner, Bayer, towards the launch of Sativex
throughout Canada in late spring."
The approval had been expected after Canadian regulators said
last December that Sativex, which is sprayed under the tongue
and contains equal amounts of THC and CBD, qualified to be
considered for approval. The company had originally hoped to
win British approval for Sativex in 2003 but UK officials said in
December they wanted more evidence about the benefits of the
medicine. It is not expected to be approved in its home market
until later this year or possibly 2006. Nevertheless, Guy said he
was confident the drug would win approval in major markets
around the world.
The approval of Sativex was welcomed by the MS Society of
Canada, whose national medical adviser Dr. William McIlroy
said sufferers needed new options to address their pain.
(Sources: Press release by GW Pharmaceuticals of 19 April
2005, Reuters of 19 April 2005)
2.
Science: THC effective in appetite and weight loss in severe lung
disease (COPD)
Patients with the severe lung disease COPD (chronic obstructive
pulmonary disease) often suffer from appetite loss and cachexia
(weight loss) resulting in reduced general well-being and early
mortality. In an open clinical study THC improved appetite and
well-being and resulted in weight gain.
18 COPD patients aged 49 to 81 years with a mean body
weight of 48.5 kg were included in the study under the guidance
of Dr. Karl-Christian Bergmann at the Clinic for Allergies and
Asthma in Bad Lippspringe, Germany. In the six months before
entering the clinic 7 participants had a constant body weight and
11 lost 2.3 kg on average.
They received 3.3-4.2 mg THC two times daily as oily drops
delivered by THC Pharm, half an hour before breakfast and
dinner. Mean treatment duration was 16 days resulting in a
considerable improvement of appetite, general well-being and
functional performance (36 per cent mean increase in walking
distance) and an average gain in body weight of 1.5 kg, which is
much regarding the short treatment period. Side effects were
mild.
(Source: Lecture by K-C Bergmann on 17 March 2005 at the
Meeting of the German Society of Pulmonology in Berlin)
3.
Science/Economy: THC inhaler offers safe and rapid delivery
On 14 April Solvay Pharmaceuticals announced the results of a
Phase I study evaluating the safety and tolerability of pulmonary
THC (dronabinol) using a metered dose inhaler.The study,
which was presented at the American Academy of Neurology
(AAN) Annual Meeting in Miami, USA, included 27 healthy
subjects who received doses between 0.3 and 9.6 mg THC.
The study found the new formulation of inhaled THC provided
rapid systemic absorption.All dose levels used in the research
were considered safe in healthy young and elderly
subjects.Dronabinol currently is available as an oral capsule,
marketed under the trade name Marinol (Solvay
Pharmaceuticals) and in Germany as dronabinol of the
companies THC Pharm and Delta 9 Pharma. Dr. Harold H.
Shlevin, president of Solvay Pharmaceuticals, said, "Pulmonary
dronabinol has potential application in a variety of conditions,
such as the treatment of migraines, nausea, pain management
and spasticity in patients with multiple sclerosis."
In mid-2005, Solvay Pharmaceuticals will launch a clinical trial
to evaluate the efficacy, safety and tolerability of pulmonary
THC delivered with a metered dose inhaler for the acute
treatment of a single moderate to severe migraine headache
attack.
(Source: Press release by Solvay Pharmaceuticals of 14 April
2005)
4.
News in brief
***Science: Weight reduction with rimonabant
Rimonabant is a CB1 receptor antagonist that blocks the effects
of endocannabinoids at this receptor. In a study with 1507
overweight subjects from Europe and the USA the drug
significantly reduced body weight within one year of treatment (5
or 20 mg rimonabant once daily). The lower dose resulted in a
mean weight reduction of 3.4 kg, the higher dose in a mean
reduction of 6.6 kg, while the placebo group lost 1.8 kg on
average. The higher dose also had a significant positive effect on
blood lipids. (Source: Van Gaal LF, et al. Lancet
2005;365(9468):1389-97)
***UK: No effect of law change on use
Contrary to claims that there has been an explosion in use since
the government decriminalized cannabis in January 2004, a new
study has found that the increase in regular use fell to just 0.5 per
cent in 2004, compared with an increase by 45 per cent at its
peak in 1998. "Our first indications are that [the change in the
law] has essentially had no effect at all in user levels of
cannabis," says Matthew Atha, director of the Independent
Drugs Monitoring Unit, which carried out the study. (Source:
The Observer of 27 March 2005)
***Science: Cannabis in HIV
523 HIV positive subjects were asked about cannabis use with
an anonymous questionnaire in the UK. 143 (27 per cent)
reported using cannabis for treating symptoms. Patients reported
improved appetite (97%), muscle pain (94%), nausea (93%),
anxiety (93%), nerve pain (90%), depression (86%), and
paresthesia (85%). (Source: Woolridge E, et al. J Pain
Symptom Manage 2005;29(4):358-67)
***Science: Medical use and driving
The effects of the synthetic cannabinoid nabilone on driving
ability was investigated in 6 patients with multiple sclerosis and
spasticity. In a crossover design they received either 2 mg
nabilone/day or placebo. No indication was found of a
deterioration of any of the five investigated neuropsychological
functions (reaction time, working memory, divided attention,
psychomotor speed and mental flexibility) during the 4-week
treatment period with nabilone. Nabilone shows similar effects
as THC, 1 mg of nabilone comparing to about 10 mg THC.
(Source: Kurzthaler I, et al. Hum Psychopharmacol 2005 Apr
18; [Electronic publication ahead of print])
***Science: Pain
A synthetic cannabinoid (GW405833) that only binds to the
CB2 receptor reduced neuropathic pain in rats. The study
supports the concept that selective CB2 receptor agonists may
have the potential to treat pain without eliciting the centrally-
mediated side effects associated with non-selective
cannabinoids. (Source: Valenzano KJ, et al.
Neuropharmacology 2005;48(5):658-72)
***The Netherlands: Office of Medicinal Cannabis
Dr. Marco J. van de Veldewas appointed head of the Office of
Medicinal Cannabis and started his new job on 1 May. He
succeeds Dr. Willem Scholten who will work with the World
Health Organisationin Geneva. Dr. van de Velde is medical
biologist and works in the Dutch Health Ministry since 1995. Dr.
Scholten was head of the Office of Medicinal Cannabis since its
formation in 2000. (Source: Newsletter of the Office of
Medicinal Cannabis of 25 April 2005)
5.
ONE YEAR AGO:
- USA: Judge ordered federal government to leave medical
cannabis centre alone
TWO YEARS AGO:
- USA: California city sue the federal government to allow
medical cannabis
- Science: Cannabinoids prevented the development of heart
failure in animal study
- Science: Immunoregulation in multipe sclerosis by cannabinoids
(More at the IACM-Bulletin archives: http://www.cannabis-
med.org/)
International Association for Cannabis as Medicine (IACM)
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Phone: 2247-968083
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Email: info@cannabis-med.org
http://www.cannabis-med.org