Sativex moved to Schedule 4 of UK Drugs Act

Published: 10-Apr-2013
Regulatory

Recognises low potential for abuse and low risk of diversion


Sativex, a treatment for spasticity in multiple sclerosis developed by GW Pharmaceuticals, a UK-based biopharmaceutical company focused on developing therapeutics from its proprietary cannabinoid product platform, has been rescheduled in the UK from Schedule 1 under the Misuse of Drugs Act to Schedule 4, part 1.

The move follows a recommendation to the Home Office by the Advisory Council on Misuse of Drugs (ACMD), which determined that Sativex has a low potential for abuse and low risk of diversion.

This ruling means that Sativex can be prescribed in the UK with no restriction on supply, recording, storage or destruction.

The change confirms the distinction between Sativex – with its evidence of quality, safety and efficacy as recognised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) – and crude herbal cannabis, which will remain on Schedule 1 of the Act.

‘This rescheduling is an important legal milestone for Sativex, both in the UK and around the world,’ said Geoffrey Guy, GW’s Chairman. ‘Achieving a low restrictive scheduling for Sativex was one of the fundamental goals that GW set out to achieve from inception and we are delighted that the extensive scientific data generated over the last decade has informed the UK government in making this important decision.’

  • Companies:
  • MHRA
  • GW Pharmaceuticals
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