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Health Canada Grants Full Approval of Sativex
For
the Treatment of Spasticity Due to Multiple Sclerosis
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Back To Main Medical Reports Page
Health Canada Grants Full Approval For GW Pharmaceuticals
For
Medical Use of Sativex For the Treatment of Spasticity Due to Multiple Sclerosis
August 31st 2010
Porton Down, UK; Toronto, Canada - August 31,
2010 - GW Pharmaceuticals plc (AIM: GWP) and
Bayer Inc., a subsidiary of Bayer AG, today
announced that Health Canada has approved
Sativex® [delta-9-tetrahydrocannabinol 27 mg/mL
(from Tetrabinex® - cannabis sativa L. extract)
and cannabidiol 25 mg/mL (from Nabidiolex® -
cannabis sativa L. extract)] as adjunctive
treatment for symptomatic relief of spasticity in
adult patients with multiple sclerosis (MS).
Sativex® is the first cannabinoid medicine
derived from whole plant extracts from the
cannabis sativa plant containing both
delta-9-tetrahydrocannabinol and cannabidiol.
This means that people in Canada with MS
experiencing the debilitating symptoms of
spasticity, such as painful spasms and cramps,
will now have a new treatment option in addition
to standard therapy.
The MS spasticity indication has received a full
marketing authorization, or Notice of Compliance
(NOC), from Health Canada. Sativex® is useful as
adjunctive treatment for symptomatic relief of
spasticity in adult patients with MS who have not
responded adequately to other therapy and who
demonstrate meaningful improvement during an
initial trial of therapy. In addition to this
new NOC, Health Canada approved Sativex® in 2005
under its Notice of Compliance with Conditions
(NOC/c) policy as adjunctive treatment for the
symptomatic relief of neuropathic pain in adult
patients with multiple sclerosis, and granted a
further NOC/c approval in 2007 as adjunctive
analgesic treatment in adult patients with
advanced cancer who experience moderate to severe
pain during the highest tolerated dose of strong
opioid therapy for persistent background pain.1
"Health Canada's approval of a third indication
for Sativex® demonstrates the broad applications
of this medicine," said Dr. Shurjeel Choudhri,
Chief Medical Officer and Head, Medical and
Scientific Affairs, Bayer Inc. "Sativex® meets a
significant unmet medical need by improving the
symptoms of spasticity in patients with MS who
have failed to respond to current anti-spasticity
medication. We believe that this approval
represents an important step forward in the
available treatment options for the MS patient
population in Canada."
Dr Stephen Wright, R&D Director, GW, said:
"Following recent approvals in the UK and Spain,
Canada is now the third major country to approve
Sativex® for symptomatic relief of spasticity in
adult patients with MS. This regulatory approval
has come several months earlier than anticipated
and GW looks forward to working with Bayer to
develop the marketing strategy for this new
indication. We are delighted that the
international regulatory program for Sativex® is
continuing its positive momentum."
http://www.gwpharm.com/Health%20Canada%20Grants%20Full%20Approval%20of%20Sativex%20For%20the%20Treatment%20of%20Spasticity%20Due%20to%20Multiple%20Sclerosis.aspx
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Back To Main Medical Reports Page
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