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GW Pharmaceuticals starts Phase III trials for Cannabis-based MS drug Sativex |
LONDON (Thomson Financial) - GW Pharmaceuticals PLC said it has started a new Phase III trial of Cannabis-based Sativex in Multiple Sclerosis (MS) Spasticity designed to secure European regulatory approval.
| The study aimed at providing compelling evidence of clinically relevant benefit for Sativex in this population of people with MS, aims to report headline results towards the end of 2008.
The company said it has completed patient recruitment for the second pivotal Phase III trial in the indication of MS neuropathic pain.
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If it does not submit the MS neuropathic pain indication, the second chance is to resubmit for MS Spasticity following completion of the MS spasticity study, GW added.
The company said in addition to the MS indications, future European regulatory submissions are planned for Sativex in cancer pain and in peripheral neuropathic pain.
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