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Posted 01-Feb-2018

Media Release: SATIVEX® (nabiximols) now available in Australia for MS spasticity

  • SATIVEX (nabiximols) is the only prescription cannabinoid medicine licensed by the TGA in Australia for the treatment of moderate and severe spasticity due to multiple sclerosis (MS)
  • Availability of SATIVEX in Australia follows UK, Canada, various European and other countries where SATIVEX is prescribed routinely for this indication

 

6th November 2017 (Sydney)

GW Pharma Ltd together with Emerge Health today announced that SATIVEX, the first and only oromucosal cannabinoid treatment, is now available on prescription (Schedule 8) in Australia for the treatment of adults with spasticity due to multiple sclerosis.

SATIVEX is registered on the Australian Register of Therapeutic Goods (ARTG) specifically for patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.1

Based on information from the NARCOMS registry of MS patients (n=20,969), 16% of the patients reported no spasticity, 31% minimal, 19% mild (occasional), 17% moderate (frequently affects activities), 13% severe (need to modify daily activities) and 4% total (prevents daily activities). About one third of the respondents reported moderate or worse spasticity despite ongoing single and multiple drug use.2

Dr John Parratt, leading Sydney neurologist, based at Royal North Shore Hospital, welcomes the availability of SATIVEX in Australia.

“Treating MS patients every day is rewarding but also challenging, especially managing symptoms such as spasticity. For these people this muscle stiffness causes rigidity and pain which may prevent them from being able to move their limbs. We have a good range of disease modifying treatments available for MS in Australia but treatment options specifically designed to address complex, interrelated symptoms like spasticity are limited. Spasticity as a symptom due to MS has a major impact on patients and carers’ lives so anything that can ease that burden is definitely useful to have as part of the treatment options” said Dr Parratt.

“There has also been a fair bit of hype around cannabis based products as a clinical solution. I think this is a great time to stress that SATIVEX, as with any pharmaceutical product registered by the TGA for use in Australia, is an approved, standardised medicine” he added.

SATIVEX is a clinically tested, standardized, cannabinoid-based medication produced from cultivated Cannabis sativa L. plants. The drug substances are partially purified extracts. The plants have been specifically bred to produce two separate chemotypes, expressing their cannabinoid content as high delta-9-tetrahydrocannabinol 2 (THC) or high cannabidiol (CBD) chemotypes. Each 100 microlitre spray contains 2.7 mg THC and 2.5 mg CBD. Each 100 microlitre spray also contains up to 0.04 g alcohol.1

SATIVEX modulates the body's endocannabinoid system, which plays an important role in signal transduction in the central nervous system.3,4 In some diseases, such as multiple sclerosis, the activity of the endocannabinoid system can be altered which in turn can lead to spasticity and other associated symptoms.5

Certain active substances from the cannabis plant, so-called Phytocannabinoids, can be used to mimic the effect of the body's endocannabinoid system and alleviate spasticity symptoms in MS.4,6

More than 1500 patients have been treated with Sativex in the clinical studies programme to date. More than 3500 patients have been monitored for safety and efficacy in observational studies in the EU with over 50,000 patient year’s exposure through clinical studies and prescription use for Sativex.7

SATIVEX is now registered across 29 countries worldwide.

Further information about the safety profile of SATIVEX can be found in the Product Information. The full SATIVEX Product Information is available at- https://tga-search.clients.funnelback.com/s/search.html?query=sativex&collection=tga-artg

PBS Information: SATIVEX is not listed on the PBS.

To read the entire media release, click here.

References:
  1. SATIVEX, Product Information Australia. Date of preparation: August 2017.
  2. Rizzo MA, et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Multiple Sclerosis. 2004:10:589-595.
  3. Pertwee RG. Cannabinoid pharmacology: the first 66 years. Br J Pharmacol 2006; 147: S163–S171
  4. Di Marzo V, Petrosino S. Endocannabinoids and the regulation of their levels in health and disease. Curr Opin Lipidol 2007;18: 129–40.
  5. Centonze et al. The endocannabinoid system is dysregulated in multiple sclerosis and in experimental autoimmune encephalomyelitis. Brain 2007;130, 2543-2553.
  6. CNS Forum. Cannabinoid receptors, 2009. http://www.dxline.org/img/term/cb1-receptor-2690_0.png.
  7. Data on file through pivotal studies and post marketing studies