Cannabis spray licence application withdrawn
23 Jul 2007
The makers of Sativex have withdrawn their EU licence application after the UK's Medicines and Healthcare products Regulatory Agency (MHRA) asked for more data to prove that it works.
GW Pharmaceuticals decided to pull its current EU regulatory application for Sativex (an oral spray derived from a cannabis extract that was developed to treat MS) after detailed discussions with the regulatory authorities.
The application process confirmed that there was enough quality and safety data to support a marketing authorisation for Sativex, but the MHRA wants more data to confirm the drug's effectiveness.
Lee Dunster, Head of Research and Information at the MS Society, said: "We know that there are around 1,500 people on Sativex in the UK and that there is a clear unmet need for pain and spasticity relief. It is disappointing that European approval has been delayed."
GW Pharmaceuticals will now seek to identify Sativex 'responders' within four weeks of treatment and confirm that their improvements are significantly better than placebo over a longer 12-week period.
Sativex is currently available on a 'named patient' basis, and will remain available through this channel. GW expects to resubmit an application in 2008.
For more information about Sativex, visit our research pages.
The application process confirmed that there was enough quality and safety data to support a marketing authorisation for Sativex, but the MHRA wants more data to confirm the drug's effectiveness.
Lee Dunster, Head of Research and Information at the MS Society, said: "We know that there are around 1,500 people on Sativex in the UK and that there is a clear unmet need for pain and spasticity relief. It is disappointing that European approval has been delayed."
GW Pharmaceuticals will now seek to identify Sativex 'responders' within four weeks of treatment and confirm that their improvements are significantly better than placebo over a longer 12-week period.
Sativex is currently available on a 'named patient' basis, and will remain available through this channel. GW expects to resubmit an application in 2008.
For more information about Sativex, visit our research pages.
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