Cannabis-derived MS drug filed for European approval

pharmafile | May 20, 2009 | News story | Research and Development, Sales and Marketing GW, Sativex 

Sativex, the cannabis-derived product developed by GW Pharmaceuticals, could be finally set for European approval after five years of delay.

Sativex has been filed with regulators for approval to treat multiple sclerosis spasticity and may win a licence by the end of 2009 after the British company supplied further clinical data.

If approved the drug will be marketed by Bayer HealthCare in the UK and by Laboratorios Almirall in the rest of the European Union.

GW's R&D director Dr Stephen Wright said: "We are pleased to have completed and filed the regulatory submission within a very short period of time of receiving the latest positive phase III data. We look forward to working with the regulatory authorities in their review of the application."

GW specialises in the use of cannabinoids, a group of molecules found only in cannabis plants that appear to have different pharmacological effects. Some cannabinoids have analgesic, anti-spasmodic, anti-convulsant, anti-tremor, anti-psychotic, anti-inflammatory and anti-oxidant properties. The company operates under license from the UK Home Office to conduct research, and grows its plants at secret locations around the country.

Sativex is GW's lead cannabinoid product and is administered as an oral spray. It became the world's first cannabis medicine to win approval in Canada in 2005, but it was hit by a string of delays in Europe, where GW had originally hoped to win approval in 2003.

GW made regulatory submissions under the European decentralised procedure, filing for approval in the UK, Denmark, Spain and the Netherlands. But UK regulator the MHRA rejected the drug in December 2004, calling for a second clinical trial to prove its efficacy.

The company has now conducted more trials and filed again in the UK and Spain under the same procedure. The UK is acting as Reference Member State in its application, which the MHRA has validated. If approved in the UK and Spain, submissions will be made in additional European countries during 2010 under the Mutual Recognition Procedure.

If GW wins a licence for Sativex the company may pursue additional indications in peripheral neuropathic pain, MS neuropathic pain and cancer pain.

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