UK Home Office has reclassified Epidiolex as a Schedule 5 medicine
GW Pharmaceuticals' Epidiolex (cannabidiol) has been moved from Schedule 2 to Schedule 5, making it exempt from virtually all controlled drug requirements. GW Pharmaceuticals has announced that the UK Home Office has reclassified Epidiolex (cannabidiol) as a Schedule 5 drug. According to the company, this change will take effect immediately in the UK's four constituent countries and the drug will be removed from Schedule 2 under the Drug Abuse Regulations 2001.
The drug is approved in the EU for the adjunctive treatment of seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in combination with clobazam, for patients two years of age and older.
“The decision to move Epidiolex to a low level of control is important for patients, their families, healthcare professionals, pharmacists and the National Health Service (NHS) as a whole and helps to lower the costs and to ensure that the drug can be dispensed more easily, ”said Chris Tovey, COO of GW. "The comprehensive pre-clinical and clinical data that GW has developed to support the drug's approval by regulatory authorities has been critical to this important change in schedule."
The UK Drug Abuse Advisory Council (ACMD) and its technical committee recommended the change of annex to the Minister of State for Crime and Police on January 29, 2020. This decision was taken after the submission of a written dossier and oral presentation by the UK Medicines and Health Products Regulatory Agency (MHRA), which drew on the extensive data set developed by GW as part of the review of the drug and its subsequent approval by regulatory authorities in September 2019.
In its recommendation to the Minister, ACMD cited "low risk of potential abuse, low risk of addiction and low risk of diversion" as the reasons for reclassifying a controlled drug from Schedule 2 to a controlled drug. of Schedule 5. The ACMD also warned that GW's medicine is "distinct from other commercially available CBD (cannabidiol) containing supplements that have not applied for marketing authorization as drug ”and that the change of list therefore applies exclusively to Epidiolex.
GW's drug is now exempt from virtually all controlled drug requirements. The company says patients and their families will now have greater flexibility over the amount of medication they can receive and benefit from repeat prescriptions, potentially reducing trips to hospital pharmacies, while healthcare professionals and pharmacists will benefit from reduced controls around the storage and reporting requirements that exist for Schedule 2 drugs.