Patient demand brings Sativex to UK ahead of approval
pharmafile | November 17, 2005 | News story | Sales and Marketing |Â Â GW Pharmaceuticals, SativexÂ
The unlicensed cannabis-based medicine Sativex will be available in the UK to treat neuropathic pain on a named patient basis following pressure from doctors and their patients.
Sativex is the second treatment to be made available on the NHS without a licence in recent weeks after health secretary Patricia Hewitt intervened to make Herceptin available for an unlicensed early-stage breast cancer indication.
Mounting media pressure and Hewitt’s intervention forced North Stoke PCT to reverse its decision and supply mother-of-four Elaine Barber with Herceptin, with wider implications for access to the drug.
Sativex was made available following requests to the Home Office from patients and doctors and a campaign by the charity Disability Now.
The pain relief spray can now be used on a named patient basis – that is for individuals whose doctors take direct personal responsibility for its use.
Sativex will be imported from Canada, where it was approved in April to treat neuropathic pain in MS, and manufacturer GW Pharmaceuticals said clearance to do this won’t affect its plans for a UK licence.
GW was told by the Medicines Commission in June to conduct further efficacy trials before the product could be approved and the company now plans to submit it to the MHRA for approval next year to treat spasticity in MS.
In addition to receiving government approval for the Canadian importer, GW had to secure a wholesaler dealer’s licence from the MHRA, which has not objected to the treatment being supplied in this way.
Sativex is the first cannabis-based medicine to be approved anywhere and GW’s first product to come to market – once approved in the UK GW’s marketing partner Bayer will promote it.
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