Sativex launched for the treatment of spasticity associated with multiple sclerosis
People with multiple sclerosis who experience spasticity now have a new treatment option with the UK launch of Sativex yesterday (21 June 2010).
Sativex, a combination cannabinoid product, is indicated as add-on treatment for symptom improvement in MS patients with moderate-to-severe spasticity that has not responded adequately to other anti-spasticity medicines. Patients must demonstrate a clinically significant improvement in spasticity-related symptoms to be eligible for ongoing treatment since not all patients will benefit. Speaking at the product’s launch, Richard Langford, consultant in anaesthetics at Barts and The London NHS Trust, said that about 50 per cent of patients will be “non-responders” to the treatment.
Sativex was developed by GW Pharmaceuticals and is being marketed in the UK by Bayer Schering Pharma. It is a combination of two extracts from the Cannabis sativa plant: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The product is a Schedule 1 Controlled Drug that, until now, has been available as an unlicensed medicine on a named patient basis. The manufacturer said it expects Sativex to be reclassified as a Schedule 4 CD in the future.
Sativex is available as a spray to be administered onto the oral mucosa (the site of the oral mucosa that is sprayed should be rotated). According to the summary of product characteristics for Sativex, the timing and number of doses will vary between patients and dose titration is required when the treatment is started to find a patient’s optimal dose. The most commonly reported adverse effects in this titration period are dizziness and somnolence. Other common side effects include amnesia, blurred vision, changes in appetite and vertigo.
Sativex is contraindicated for patients with a history, or family history, of schizophrenia or other psychiatric conditions (other than depression) and for women who are breastfeeding. The manufacturer does not recommend Sativex for patients under 18 years of age or those with serious cardiovascular disease. They recommend that caution should be taken when treating patients with a history of epilepsy or recurrent seizures.
Jayne Spink, director of policy and research at the MS Society, called for an update to the National Institute for Health and Clinical Excellence guidelines for the treatment of MS. The guidelines were last published in 2003 and are expected to be updated by NICE at the end of this year.
Action: Partial agonist at cannabinoid receptors in the central nervous system, including those associated with movement and postural control.
Dose: Oral spray (each 100microlitre spray contains 2.7mg THC and 2.5mg CBD). The number and timing of doses will vary between patients; the maximum recommended dose is 12 sprays per day.
Cost: 10ml container (90 sprays), £125.
Citation: The Pharmaceutical Journal URI: 11014810
Recommended from Pharmaceutical Press