Sativex Has No Long-Term Negative Effect on Cognition

LONDON, Aug. 5,2013 /PRNewswire/ --GW Pharmaceuticals plc (NASDAQ:
GWPH, AIM: GWP, "GW," "the Company" or "the Group"), a biopharmaceutical
company focused on discovering, developing and commercializing novel
therapeutics from its proprietary cannabinoid product platform, announces top-
line results from a 12 month placebo-controlled study of Sativex in patients with
spasticity due to Multiple Sclerosis (MS). The study results confirm the
reassuring safety profile of Sativex and provide further evidence of long-term
efficacy.
The study was a 12 month multicentre, double-blind, randomised parallel
group, placebo-controlled study in 121 patients with MS spasticity. The study
was required as a post-approval commitment by the UK regulatory authority, the
Medicines and Healthcare products Regulatory agency (MHRA), with the primary
objective of evaluating whether Sativex may have long term adverse effects on
cognitive function or mood. The primary endpoint was the change in cognitive
function as assessed by the total Paced Auditory Serial Addition Test (PASAT)
score from baseline to end of treatment. Mood was assessed by the Beck
Depression Inventory-II.
There was a slight improvement in the PASAT score from the beginning to the
end of the study in both the Sativex and placebo groups, thus confirming that
there is no evidence of long-term cognitive impairment in patients taking Sativex
compared with those taking placebo. Similarly, the change in mood over the 12
month period was more or less identical in the Sativex and the placebo group,
confirming no untoward effect on mood.
The key efficacy secondary endpoints were the global impression of change
scores as assessed by the patient, physician and carer. Each of these endpoints
was highly significantly in favour of Sativex (p<0.0001, p=0.001 and p=0.004
respectively).
Detailed data from this study is due to be presented at the 29th Congress of the
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) on 2-5 October in Copenhagen, Denmark.
Dr Stephen Wright, GW's R&D Director, said, "We are pleased to report positive
and wholly reassuring results from this 12 month placebo-controlled study in
patients with MS spasticity. We have now shown that Sativex does not impair
cognition either in short-term or in long-term use in well designed, randomised,
placebo controlled clinical trials. These data not only confirm the good
tolerability of Sativex in long-term use but also provide further evidence of
efficacy consistent with that seen in previous shorter duration clinical trials."
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering,
developing and commercializing novel therapeutics from its proprietary
cannabinoid product platform in a broad range of disease areas. GW
commercialized the world's first plant-derived cannabinoid prescription drug,
Sativex®, which is approved for the treatment of spasticity due to multiple
sclerosis in 22 countries. Sativex is also in Phase 3 clinical development as a
potential treatment of pain in people with advanced cancer. This Phase 3
program is intended to support the submission of a New Drug Application for
Sativex in cancer pain with the U.S. Food and Drug Administration and in other
markets around the world. GW has established a world leading position in the
development of plant-derived cannabinoid therapeutics and has a deep pipeline
of additional cannabinoid product candidates, including two distinct
compounds, GWP42004 and GWP42003, in Phase 2 clinical development for
Type 2 diabetes and ulcerative colitis, respectively, and at least two additional
programs expected to enter Phase 1 and Phase 2 clinical trials in the next 12
months. For further information, please visit www.gwpharm.com