Bayer Schering Pharma UK, today announces that Sativex Oromucosal Spray has been granted a licence and is now available in the UK as a prescription-only medicine.
This is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant containing both delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). This means that people with Multiple Sclerosis (MS) experiencing the debilitating symptoms of spasticity, such as painful spasms and cramps, will now have a new treatment option in addition to standard therapy.
Sativex is indicated as add-on treatment for symptom improvement in patients with moderate to severe spasticity due to 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.
Sativex has been shown to provide significant improvement in the numeric rating scale (NRS) spasticity score, and spasm frequency compared with placebo.
After a four-week, single-blind therapeutic trial period in 572 patients, Sativex reduced a mean 0-10 NRS score for spasticity by 3.01 points, from a baseline of 6.91 points.2 48% of patients achieved a 20% improvement in mean spasticity NRS during this initial period.
Of these responders, 241 proceeded into a 12-week, randomised, placebo-controlled trial phase.
At the end of the trial, Sativex had reduced the mean spasticity 0-10 NRS in responders by significantly more than placebo (estimated treatment difference 0.84 points; p=0.0002).
The number of patients achieving an improvement in spasticity NRS of 30% during the randomised phase of the trial was significantly greater in the Sativex group than the placebo group (74% vs. 51%; p=0.0003).
Commenting on the availability of Sativex, Professor John Zajicek, Consultant in Neurology, Derriford Hospital, Plymouth said, “The launch of Sativex is a milestone in the journey of cannabinoid medicines. Current standard therapy for MS associated spasticity can produce side effects which patients may find difficult to cope with and not all of them are specifically licensed for spasticity. Sativex on the other hand has mainly mild to moderate side effects, which can be easily controlled by adjusting the dose. It has really benefited those people who have found it effective and is a useful addition to available treatments. ”
Sativex is only available on prescription from a physician with experience in treating MS spasticity. It is sprayed into the mouth either onto the inside of the cheek or under the tongue. The MS patient decides how many sprays they need in any one day with a typical patient taking 8 sprays a day (daily limit of up to 12 sprays). Extensive clinical trials mean that there is now approximately one thousand patient years exposure to Sativex in the UK. The NHS price of Sativex is £125 per 10ml vial which for a typical patient is approximately £11 per day.
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