UK Home office reclassifies Epidyolex as a Schedule 5 drug
pharmafile | June 24, 2020 | News story | Research and Development | CBD, cannabiodiol, cannabis
The Home Office has announced that the drug Epidyolex (cannabidiol) has been reclassified as a Schedule 5 drug, a move from a Schedule 2 substance under the Misuse of Drugs Regulation 2001.
Kit Malthouse, the Minister of State for Crime and Policing, the Advisory Council on the Misuse of Drugs (ACMD) and its Technical Committee Recommend the change back on 29 January 2020. This followed a written dossier submitted by the MHRA using data developed by GW Pharmaceuticals, the creators of the drug, which was used for its approval by regulatory authorities in September 2019.
In its recommendation to the Minister, the ACMD said the treatment had a low risk of abuse potential as well as a low risk of dependency and cited these as reasons for the reclassification of the drug. However, they warned that GW’s product was different from other cannabis products so the change applies exclusively to Epidyolex.
Chris Tovey, GW’s Chief Operating Officer, said: “The decision to move EPIDYOLEX to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole – reducing costs and ensuring the medicine can be dispensed more easily. The extensive pre-clinical and clinical data that GW developed to support the medicine’s approval by regulatory authorities was pivotal to this important schedule change, and we would like to thank the MHRA, ACMD and Home Office for scrutinising this data and making this change in such a short timeframe.”
“We remain committed to expanding the high-quality evidence base for cannabis-based medicines and securing further regulatory approvals because doing so is in the interests of patients and healthcare professionals and can support further rescheduling.”
The recommendation was accepted by Malthouse on 22 April and legislation was tabled to enact change on 3 June 2020. The product is now exempt from all controlled drug requirements and patients can have more flexibility on the amount of this medicine they receive.
Conor Kavanagh
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