Wales Poised to Approve Cannabis-based Multiple Sclerosis Medication

The cannabis-based multiple sclerosis (MS) drug Sativex has been recommended for use in Wales, making it the first in the United Kingdom to do so. The drug awaits final approval from the government.

GW Pharmaceuticals’ drug was approved Aug. 15 by the All Wales Medicines Strategy Group (AWMSG), a Welsh Assembly-sponsored public body similar to an US Food and Drug Administration recommendation body. The oral spray is designed as a combination drug to treat muscle spasms in MS patients who have not responded well, if at all, to other medicines.

“Muscle spasms and stiffness in MS can be painful and distressing and so the availability of a treatment that can potentially alleviate these symptoms is good news,” Wales’ MS Society program director Sally Hughes told BBC News. “We particularly welcome this decision considering the draft NICE (National Institute for Health and Care Excellence) clinical guideline, published in April, rejected this treatment for use on the National Health Service (NHS) in Wales and England based on a flawed assessment of the drug’s cost effectiveness.”

The drug was launched in 2010 after GW noticed an unmet need for MS treatments and conducted 11 years’ worth of research. The MS patient may determine the number of sprays required, but typically 8 are needed. There is a daily limit of 12 sprays. Sativex can be sprayed into the mouth either onto the inside of the cheek or under the tongue.

“Sativex represents a welcome advance in MS symptom treatment,” Geoffrey Guy, chairman of GW, said in a 2010 press release. “Our cannabinoid technology platform and enables us to progress the development of our pipeline across a range of therapeutic areas with increased confidence.”

The active ingredients in Sativex are a one-to-one ratio of delta-9-tetrahydrocannabinol (THC) and cannabidol (CBD), which are both derived from cannabis sativa plant extract. CBD acts as an anti-inflammatory, anticonvulsant, antipsychotic, anti-oxidant, neuroprotective, immunomodulatory ingredient in Sativex. Similarly, THC acts as the analgesic, anti-spasmodic, anti-tremor, anti-inflammatory, appetite stimulant, anti-emetic component.

Side effects of Sativex include dizziness — mostly during the first few weeks of treatment — and fatigue. The NHS of Wales estimates the price of Sativex is GBP 125 per 10 milliliter vial, which is approximately GBP 11 per day.

Though Sativex soon may be available in Wales, England may block the drug due to differences in NICE guidelines. With Sativex acting as a catalyst, NICE announced plans to update its MS treatment guidelines for the first time in a decade. However, the NICE guidelines will not affect the Welsh ruling. The medication has been available for strict licensed use since its launch in 2010.

Sativex is not available in the United States. However, GW Pharmaceuticals is pursuing Phase III trials with Sativex for cancer pain. No plan has been created to test Sativex for MS in the United States.