A user-friendly guide on Sativex ®

What is Sativex?

Sativex

Sativex® , by the words of the Pharmaceutical company which produces it, (GW Pharmaceuticals) is the “ world’s first prescription cannabis medicine”, containing the two active ingredients Δ-9 THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol) that make up cannabis plant.

This medicine has been fully authorized in the UK by 2010 for the treatment of spasticity due to Multiple Sclerosis (MS), and is usually prescribed in addition to the current anti-spasticity medications, whereas these have not improved symptoms adequately.

Sativex ® comes in form of a light brown coloured liquid that can be easily sprayed in the mouth (is an oromucosal spray)– on the inside of the cheek or sub-lingual (under the tongue).

The posology as well as dietary and drug interactions are further described here.

Sativex: Current therapeutic role

Multiple Sclerosis

Sativex® is currently approved (for the full list of Countries see section below) for the relieve of muscle stiffness, weakness and ataxia (impaired coordination).

These symptoms are experienced by 85% of MS as well as cerebral palsy and spinal cord injuries patients. They provoke pain, spasms and ultimately reduced mobility.

Worldwide more than 1.2 million people suffer from Multiple Sclerosis (the majority of which are aged between 20 and 40 years old) and the current therapies for spasticity include baclofen, tizanidine, dantrolene and diazepam; all of which have been widely recognised to induce significant side effects and yield limited efficacy. (World Health Organisation)

Sativex® has been developed as a treatment for the relief of symptoms in patients with moderate to severe spasticity that have not been adequately treated with currently used therapies.

It improves other symptoms often experienced by these patients, such as tremor, urinary and sleep disturbances.

It has been shown that after 10 years since symptoms onset 90% of patients with MS develop  bladder dysfunction.

Sativex® diminishes nocturia (nocturnal need to void), daytime frequency, general urgency-incontinence and pain in the urinary tract, which “significantly improved quality of life scores” for the participants of the studies.

For an accurate review of all the studies of Sativex® for MS, please click here. For better understanding the use of cannabinoids in the treatment & management of MS, click here.

Chronic Pain

(Cancer, post-operative, neuropathic, phantom limb)

It has been estimated that 7-8% of the entire population in Western Countries develops neuropathic pain: a chronic, debilitating condition that arises from neural or metabolic dysfunction or in co-morbidity with other diseases, such as MS, cancer, diabetes, HIV, physical injury or stroke. (Selph et al. 2011, Scadding 2003)

Neuropathic pain is described as “unpleasant burning or shooting sensations, or extreme sensitivity to touch” and the current therapies (opioids, tryciclic antidepressants and benzodiazepines) yield a poor outcome, due to lack of a long term therapeutic benefit. Tolerance is rapidly developed and doses must be increased throughout, so that over time the side effects associated with the use of these drugs (constipation, sedation, respiratory depression and addiction) exceed the curative potential. See more here (Kehl et al., 2003)

Even when treated with the highest tolerated dose of strong opioid, many cancer patients do not find relief from severe pain (a percentage that rises with the progression of the disease, usually around 70%, depending as well from the type of cancer); for these as well as MS patients experiencing neuropathic pain, Canada has approved Sativex® as adjunctive analgesic, which aids pain management free of opioid-related side effects. (Click here for further studies on synergy cannabinoids-opioids).

Phase 3 trials for cancer pain are currently undergoing for cancer pain at hospital sites in the United States, Europe and Mexico.

Sativex® has also been used in a number of Phase II and III clinical trials in various models of peripheral neuropathic pain, from which a body of positive data has been generated.

Other approved therapeutic uses of cannabinoids (also in the form of capsules- Marinol/Dronabinol, Nabilone/Cesamet- and vaporisers-inhalers) include antiemetic effect (controls nausea for cancer patients undergoing chemotherapy), appetite stimulant for AIDS anorexia-cachexia (wasting syndrome) and weight loss due to chemotherapy. Sativex® is prescribed to these patients in Catalonia, Spain, Germany & Italy.

Under exploration

Undergoing studies are addressing other uses of Sativex (and generally cannabinoid-based medicines) for the treatment of anxiety and depression, asthma, brain damage, cancer (glioblastoma multiforme), Crohn’s Disease, epilepsy (For Dravet’s Syndrome it has been recently FDA-approved (Epidiolex®), fibromyalgia, glaucoma, inflammatory diseases, metabolic diseases, migraine, movement disorders, neurodegeneration, rheumatoid arthritis and schizophrenia.

Where can you get Sativex ®?

Commercialisation Sativex

Note to the reader: this article dates back to 2014. Regulations have changed and many more Countries are now included within this list. Please check directly on GW’s website or their commercial partner’s in the lists below.

Sativex® is now marketed as a prescribed treatment for MS spasticity in Austria, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, New Zealand, Spain, Sweden. Switzerland and the UK.

Sativex® has also been approved/recommended for approval by regulatory authorities in Belgium, Finland, Iceland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.

Regulatory applications are underway/being prepared in selected countries in the Middle East and Asia.

The United States required further trials of Sativex for MS spasticity as well as for cancer pain and 2014 is the date intended for approval.

Canada and Israel are currently the only Countries that approved and marketed Sativex® an an adjunctive analgesic for the relief of neuropathic pain in MS and cancer pain.

Extension to other Countries of Sativex® for cancer pain and neuropathic pain will be a reality of the near future, as Phase III trials (for the former) and Phase II (for the latter) are undergoing as you read.

Many of the Countries listed above have accepted a Mutual Recognition Program, meaning that national pricing and reimbursement will be dependent from each Nation and the marketing rights of the licensed commercial partner of GW Pharmaceuticals plc.

Find the list below of the commercial partners, as well as a direct link to the requirements for supply for each Country.

• UK  and Canada– Bayer
• EU (excluding the UK)+Switzerland + Norway + Mexico and Turkey- Almirall S.A.
• USA –Otsuka Pharmaceutical Co. Ltd
• Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), Middle East
• (excluding Israel/Palestine) and Africa – Novartis

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