Porton Down, UK, 9 August 2006 - GW Pharmaceuticals plc (AIM: GWP) announces the start of a second pivotal Phase III trial in people with multiple sclerosis (MS) suffering from central neuropathic pain. The first patient has now been enrolled in the study.
This Phase III study is a double-blind randomised placebo-controlled study of Sativex in 218 patients with central neuropathic pain due to MS, who have achieved inadequate pain relief with existing therapies. This study therefore aims to address a currently unmet medical need and will be recruiting patients in the UK, Canada, France, Spain and the Czech Republic. The primary outcome measure in the study is the 0-10 Numeric Rating Scale pain score, as recommended by regulatory authorities in both Europe and North America. The study is expected to report headline results in about one year.
GW has previously carried out a similar pivotal Phase III study with positive results. This study, which was published in the peer-reviewed journal, Neurology, showed that Sativex was significantly superior to placebo in reducing pain (p=0.005) and sleep disturbance (p=0.003)1.
It is regulatory convention for two pivotal Phase III trials in the same patient population to be required to support a product approval for a particular indication. This second pivotal Phase III study in MS Neuropathic Pain has a number of important roles in the regulatory strategy for Sativex, as follows:
In Europe, this second pivotal study will complete a clinical data package to support a regulatory submission for Sativex in the indication of "MS Neuropathic Pain"
In Europe, this study is intended to enhance the data package arising from GW's two ongoing peripheral neuropathic pain studies, to support a broad indication of "General Neuropathic Pain" as identified in recent EU guidelines
In Canada, this study is intended to meet the conditions associated with the approval of Sativex in order to obtain a full Notice of Compliance.
Sativex is already approved in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in MS. Canada was the first country in the world to approve Sativex. Health Canada approved Sativex under the Notice of Compliance with Conditions policy.
Dr Stephen Wright, R&D Director, said, "GW has in place a broad regulatory strategy to support the global approval of Sativex across multiple related indications including neuropathic pain and spasticity in multiple sclerosis, peripheral neuropathic pain and cancer pain. One of the principal purposes of this study is to complete the regulatory package required for the approval in Europe of Sativex in the indication of neuropathic pain in MS.
"Neuropathic pain is a debilitating symptom of MS and is often under treated and inadequately controlled. Our data show that Sativex has a valuable role to play in treating this significant unmet medical need."
GW Pharmaceuticals plc Today: +44 (0)20 7831 3113
Justin Gover, Managing Director
Financial Dynamics Tel: +44 (0)20 7831 3113
Notes to Editors
Sativex is derived from whole plant extracts of two specifically bred cannabis plant varieties. The extracts are combined to produce a standardised formulation containing two major components of cannabis, the cannabinoids Ä9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Sativex is formulated into a pump action oromucosal (mouth) spray designed for self-administration by the patient. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD.
Sativex Phase III Trials Programme
GW's ongoing Phase III trials programme has been the subject of formal regulatory advice in Europe and North America and is designed to obtain approvals for Sativex across global markets in the following indications. This programme is summarized below:
Peripheral neuropathic pain
Two Phase III studies in the peripheral neuropathic pain indication are due to complete before the end of this year. These studies meet formal pan-European regulatory guidelines in the indication of peripheral neuropathic pain and would support a filing in this indication in Europe.
Neuropathic pain in MS
This indication is approved in Canada. The Phase III MS neuropathic pain trial started today complements the positive Phase III study already completed, and will provide data for a filing in this indication in Europe.
General neuropathic pain
The three studies listed above will together provide a regulatory package in Europe for the broad indication of general neuropathic pain.
Spasticity in MS
GW has previously reported two pivotal Phase III in MS spasticity, Regulatory advice meetings being held to consider possibility of MS spasticity submission in Europe. Decision to be taken in second half of 2006.
The FDA has accepted an IND for Sativex to commence Phase III trials in the US for this indication. The first trial is due to commence around the end of this year. US development will also contribute to a future European filing in this indication.
Central Neuropathic Pain
Neuropathic pain is caused by damage to or dysfunction of the nervous system. It is usually chronic and accompanied by unpleasant burning or shooting sensations, or extreme sensitivity to touch.
It is estimated that at least 2.4% of the world's population suffers from neuropathic pain2, including over 1.4 million patients in UK.
It is estimated that central neuropathic pain (pain initiated or caused by damage to the central nervous system, i.e. brain or spinal cord) occurs in up to 52% of people with multiple sclerosis3. Up to 32% of patients with MS regard pain among their most severe symptoms4 describing it as frequent, disabling and inadequately managed5.
About GW Pharmaceuticals plc
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange in June 2001. Operating under license from the UK Home Office, the company is developing cannabis-derived pharmaceutical products for patients with multiple sclerosis, neuropathic pain, cancer pain, spinal cord injury, rheumatoid arthritis, and other severe medical conditions.
GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW is dedicated to developing treatment options that alleviate pain symptoms in patients who suffer from serious ailments.
For further information, please visit the Company's website:www.gwpharm.com
1. D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005;65:812
2. Neuropathy Trust 2005.www.neurocentre.com(Source September 2005)
3. Biovie J. Central Pain. In: Wall PD, Melzack R, eds. Textbook of pain, 4th ed. Hong Kong: Harcourt Publishers Ltd, 1999:879-914
4. Stenager E, Knudsen L, Jensen K. Acute and chronic pain syndromes in multiple sclerosis. Acta Neurol Scand 1991;84:197-200
5. Thompson AJ. Symptomatic treatment in multiple sclerosis. Curr Opin Neurol 1998;11(4):III05-III09