GWP GW Pharm.

    RNS Number : 8715C
  GW Pharmaceuticals PLC
  08 September 2008
   
GW Pharmaceuticals plc
 
POSITIVE SATIVEX� STUDY CONFIRMS LONG TERM EFFICACY IN MS NEUROPATHIC PAIN
 
Results Support Design of Ongoing Phase III MS Spasticity Study
 
Porton Down, UK, 8 September 2008: GW Pharmaceuticals plc (GWP:AIM) announces positive results from a placebo-controlled *randomized
withdrawal* study of Sativex� in patients with neuropathic pain due to Multiple Sclerosis (MS). This study design is described by regulators
as being sufficient to satisfy the need for long-term efficacy data.
 
This randomized withdrawal study evaluated 42 MS patients with central neuropathic pain who had previously been in a Sativex Phase III MS
neuropathic pain study and who continued to take Sativex on an open label basis for 12 weeks. They were then randomized to Sativex or
placebo for a further 4 weeks in a double-blinded manner. During the randomized period, patients were not permitted to adjust their dose.
The purpose of this blinded 4-week *randomized withdrawal* study was to assess the maintenance of pain control in patients who remain on
Sativex versus those who switch to placebo.
 
In the patients who were randomized to Sativex pain scores remained stable. In the patients randomized to placebo, pain and sleep scores
deteriorated. The prospectively defined primary efficacy endpoint of the study - the time to treatment failure - was statistically
significantly in favour of Sativex (p=0.036). The difference between Sativex and placebo was also significant for mean pain score (p=0.028)
and sleep quality (p=0.015). The results of all other symptom-related endpoints showed that Sativex patients maintained or improved their
response whilst the symptoms of those who switched from Sativex to placebo worsened in the 4 weeks following cessation of active treatment.
During the randomized withdrawal period, there were 2 patients with adverse events on Sativex, and 5 on placebo. One patient on placebo
withdrew from the study. There was no evidence of any withdrawal syndrome.
 
Until now, all the evidence for long-term maintenance of efficacy of Sativex has come from long-term open-label exposure(1). The results
reported today confirm in the context of a placebo-controlled double-blind study that efficacy is indeed maintained in long-term use. 
 
The results of this study are of further significance to GW since the design bears important similarities to the ongoing Phase III MS
spasticity study requested by the UK regulator prior to granting approval for Sativex. This ongoing Phase III study involves all patients
receiving Sativex for 4 weeks, following which Sativex responders are randomized to continue on Sativex or switch to placebo for a further
12 weeks. This study is due to report results in Q1 2009 with a regulatory submission targeted for H1 09.
 
Dr Stephen Wright, GW*s R&D Director, said: *This is the first placebo-controlled study showing that Sativex provides long term efficacy for
MS patients with neuropathic pain and supplements previously published open-label studies. In addition, these results support the design of
the ongoing Phase III trial in MS spasticity. It is encouraging to note that if the difference between Sativex and placebo achieved in the
results today are replicated in the ongoing Phase III MS spasticity study, this Phase III study will meet its objectives.*
 
Enquiries:
 
 GW Pharmaceuticals plc                    (Today)+ 44 20 7831 3113
 Dr Geoffrey Guy, Executive Chairman  (Thereafter) + 44 1980 557000
 Justin Gover, Managing Director                                   
                                                                   
 Financial Dynamics                               + 44 20 7831 3113
 David Yates / John Dineen                                         
 
 
Notes to Editors
 
About GW
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 researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in
particular pain and other neurological symptoms. 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 occupies a world leading position in
cannabinoids and has developed an extensive international network of the most prominent scientists in the field.
 
1. Rog DJ et al. Clinical Therapeutics. 2007; 29: 2068-2079
 

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