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Sativex®
Canninoid derived oral spray developed for the treatment of MS-related pain and spasticity.
Apparently effective for pain, muscle spasms and depression. For symptomatic relief
only, does not affect the underlying condition.
Cannabis based MS drug Sativex approved by British medical authorities
GW Pharmaceuticals Plc's cannabis-
The much-
Clinical trials have shown GW's Sativex, which is sprayed under the tongue, reduces spasticity in multiple sclerosis (MS) in patients who do not respond adequately to existing therapies.
It became the world's first cannabis medicine to win regulatory clearance when it
was approved in Canada in 2005 for neuropathic pain but its roll-
A green light from the MHRA had been expected before the end of June but confirmation
of approval will still be a relief to investors, who have seen a series of delays
with the product. GW had originally hoped to win approval in 2003 for its drug -
GW said last month it also expected a regulatory green light in Spain shortly after the British approval, with other European countries following later. Sativex will be sold in the rest of Europe outside Britain by Spanish drugmaker Almirall.
GW will receive a 10 million pounds ($15 million) milestone payment from Bayer as a result of British approval, while a further 2.5 million pounds is payable by Almirall following both regulatory and pricing approval in Spain.
WILL NHS PAY FOR IT?
Questions remain about Sativex's commercial potential. In particular, the rate of uptake in Britain will likely be limited until the National Institute for Health and Clinical Excellence (NICE) decides whether it should be reimbursed on the National Health Service (NHS).
Analysts at Piper Jaffray, which acts as adviser to GW, forecast that peak sales
in MS spasticity could reach 121 million pounds in Europe and Canada combined. The
drug could also be used longer-
Shawn Manning, an analyst at Singer Capital Markets, said a green light for cancer pain in the United States would be a major commercial breakthrough.
"That's a real opportunity, that will be the big market -
Source: Reuters © Copyright 2010 Thomson Reuters (18/06/10)
Notes
2005 saw the approval of Sativex in Canada for use in controlling MS pain. At the time GW Pharmaceuticals said “We remain committed to securing approval of Sativex across Europe and elsewhere. In the UK results of a study in September 2005 indicated that Cannabis based Satives® significantly reduces Central Neuropathic Pain in people with Multiple Sclerosis.
In November 2005 the Home Office said the treatment could be imported to the UK for individual patient’s use on a Named Patient Basis, however, problems arose over Primary Care Trusts throughout the country actually approving payments for the drug.
The year (2005) ended with yet another “post code lottery” with regards to the availability of Sativex on the NHS.
In December GW Pharmaceuticals announced it had struck a deal with Spain’s Almirall to market Sativex in European countries excluding the UK.
Sativex was granted a licence by the Canadian regulatory authority, April 2005, as
an add-
A study paper published in ‘the Journal of Clinical Therapeutics’ indicates that Sativex provides an effective long term treatment for central neuropathic pain.
A new phase 3 trial had begun designed to satisfy the regulators.
Results should be known by the end of 2008
The study follows a design which first identifies responders over a four week period (phase A),and then focuses on analysing the effect of Sativex vs placebo on those responders over a further 12 weeks (phase B)
Source -
The Medicines and Healthcare Products Regulatory Agency (MHRA) has published a ‘public information report’ on Sativex
Their statement said that it considered it "in the interest of public health to provide potential prescribers with information on the MHRA's assessment of quality, safety and efficacy of Sativex in the relief of spasticity in people with muscular sclerosis"
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