Tuesday , September 05, 2006
Sativex, the cannabis-derived product developed by GW Pharmaceuticals could be finally set for approval after a delay of around two years.
UK regulator, the MHRA, rejected the drug in December 2004, calling for a second clinical trial to prove its efficacy, which the company has now conducted, and which, it believes, proves that Sativex works.
The company is seeking to treat multiple sclerosis spasticity, but hopes to eventually gain licences to treat peripheral neuropathic pain, MS neuropathic pain and cancer pain as well.
GW Pharmaceuticals has filed Sativex for approval through the decentralised procedure for licences in just four European countries, the UK, Denmark, Spain and the Netherlands.
Once approved, Sativex will be marketed in the UK by Bayer HealthCare and in the rest of Europe by Almirall.
Dr Stephen Wright, GW's R&D Director said: "We now have a sizeable body of positive clinical data to support the efficacy and safety of Sativex in MS spasticity. This is a complex data package and we have therefore reviewed the complete dossier with our marketing partners and discussed it in detail with a number of European regulators.
"These meetings have provided constructive and positive feedback. The conclusion of GW and its marketing partners, taking into account the views of the regulators, as well as the unmet needs of this target patient group, is that this body of data warrants serious regulatory evaluation."
Dr Geoffrey Guy, executive chairman of GW added: "This filing is one element of a broad-based regulatory strategy for Sativex, which is designed to maximise the opportunities for Sativex as well as to manage the risks associated with its development.
"Beyond the filing today in MS spasticity, the Phase III clinical trials programme continues and will provide further sets of clinical data to support additional regulatory filings in separate indications. This approach is aimed at creating several independent opportunities to obtain regulatory approvals for Sativex in the coming years."
Sativex is already approved in Canada to treat MS neuropathic pain and the company recently started a further phase III study in this indication. The study will complement existing phase III trial data, with a filing in Europe based on the results expected by the first half of 2008.