Novel cannabis derived treatment for MS pain now available in Canada by prescription  

TORONTO, ONTARIO, CANADA

Sativex(R) (Cannabis sativa L.  extract), the only adjunctive treatment for symptomatic relief of neuropathic pain in adults with multiple sclerosis (MS), is now available in Canada.  The novel treatment can now be obtained by prescription through Canadian pharmacies. 

In April 2005, Canada became the first country in the world to approve Sativex, an effective and safe cannabis derived prescription medicine.   Health Canada has approved Sativex with conditions, under the Notice of Compliance with Conditions (NOC/c) policy.  This authorization reflects the promising nature of the clinical evidence which will be confirmed with further studies.  Products approved under Health Canada's NOC/c policy, have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment for the approved use.  

"Effective pain control and management are extremely important in a disease like MS," said Dr.  Allan Gordon, Neurologist and Director of the Wasser Pain Management Centre, and of the Edward Bronfman Family Foundation MS Research Clinic at Mount Sinai Hospital, Toronto, Ontario. 

"The availability of Sativex addresses the great demand for an effective treatment option in the field of neuropathic pain in MS.  Many patients, including some in my own practice, report using cannabis for relief of their pain.  People with MS and neuropathic pain should speak to their doctor to determine whether Sativex is an appropriate option for them."

1.    How it Works

2.    Principal Components

3.    Neuropathic Pain

4.    Efficacy

5.    Side-effects.

 How it works:

 Sativex is administered through a spray pump under the tongue or on the inside of the cheek, providing reliable, self-administered pain relief.  The spray formulation allows for more flexible dosing than an oral tablet, well suited to the variable nature of neuropathic pain experienced by people with MS.   "Sativex will be welcomed by the Canadian MS community," said Dr.  William J.  McIlroy, National Medical Advisor, Multiple Sclerosis Society of Canada.  "Neuropathic pain associated with MS is often under treated and under controlled.  The availability of Sativex will now allow people living with MS and neuropathic pain a new treatment option to address one of the more debilitating symptoms associated with the disease." 

Principal components:

Sativex is a product resulting from the pioneering research efforts of UK-based GW Pharmaceuticals plc and is marketed in Canada by Bayer HealthCare, Pharmaceuticals Division.   Its principal active cannabinoid components are delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD).(1) The ratio of THC to CBD in Sativex is 2.7 mg : 2.5 mg per spray, ensuring a standardized dose is delivered each time it is used.   

Neuropathic pain:

  Pain is a common symptom of MS occurring in up to 86 per cent of people with MS.(2) Neuropathic or nerve pain can occur spontaneously or can be provoked by touch, temperature or movement.  It is estimated that 50 per cent of people with MS suffer from chronic neuropathic pain.(3,4,5) The most common descriptions of neuropathic pain are of freezing, cold or burning sensations usually of the limbs and most often of the lower extremities.(6) Many individuals with neuropathic pain respond inadequately to current treatment options.(7,8)  

Data demonstrates efficacy(1):

  While there is no complete cure for MS or neuropathic pain, a double- blind placebo controlled parallel group study demonstrated that Sativex provided significantly greater pain relief than placebo.  Sativex also significantly reduced pain-related sleep disturbance.   

Sativex and side-effects(1):

  In clinical trials, the most frequent side-effects included nausea, fatigue, dizziness and application site reactions.  Side-effects were usually mild or moderate in severity and often resolved with down-titration or interruption of treatment.  

 Multiple sclerosis (MS) in Canada(9)

  MS is a disease of the central nervous system and is the most common neurological disease affecting young adults in Canada.  Approximately 50,000 Canadian men and women have the disease and each day approximately three more people are diagnosed.  MS is most often diagnosed in people between the ages of 20 to 40 years of age.     

References:  --------------------- 

(1) Sativex Product Monograph - April 2005 

(2) Ehde DM, et al.  Multiple Sclerosis 2003; 9; 605-611.  

(3) Archibald CJ, et al.  Pain 1994; 58:89-93.  

(4) Sketris IS, et al.  Clinical Therapeutics 1996; 18(2):303-318. 

(5) Moulin DE, et al.  Neurology 1988;38:1830-1834.