The UK Home Office has reclassified Epidyolex (cannabidiol) as a Schedule 5 drug from its former classification as a Schedule 2 medicine under the Misuse of Drugs Regulations act 2001.
The medicine is approved in the EU for adjunctive therapy of seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients from two years of age and older.
The move to reclassify the drug means that it is now exempt from virtually all controlled drug requirements.
As such, patients and their families will now have greater flexibility on the quantity of medicine they can receive and be able to benefit from repeat prescriptions, whilst healthcare professionals and pharmacists will benefit from reduced controls around the storage and reporting requirements that exist for medicines under Schedule 2, GW noted.
“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,” said Chris Tovey, the firm's chief operating officer.
“The extensive preclinical 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.”