GW’s cannabis-based medicine rescheduled following approval by the European Medicines Agency (EMA) and an independent assessment by the Advisory Council on the Misuse of Drugs (ACMD)
Burden on patients, their families and healthcare professionals eased due to the reduction in controlled drug requirements
GW Pharmaceuticals plc, discovers, develops and delivers regulatory approved cannabis-based medicines, announced the reclassification of EPIDYOLEX (cannabidiol) by the UK Home Office as a Schedule 5 drug. The change is effective immediately in constituent nations across the UK while Northern Ireland enact the medicine as a separate legislation and move from the Schedule 2 to Schedule 5 subject to the Misuse of Drugs Regulations 2001.
GW’s Chief Operating Officer Chris Tovey said that this development moving EPIDYOLEX medicine to a low level of control is crucial for the patients as well as healthcare professionals, pharmacists and the NHS as a whole because as now costs will be low and it will ensure the medicine can be dispensed more easily. The company is committed to flourish the high-quality evidence base for medicines on cannabis and trying to secure further regulatory approvals as it is in the interests of patients and healthcare professionals and can help in further rescheduling of the drugs. He further added, “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.”
On 29 January 2020, the medicine got the recommendation of schedule change by the ACMD and its Technical Committee recommended to Kit Malthouse MP, Minister of State for Crime and Policing. MHRA submitted written dossier and oral presentation on the GW developed substantial data package in the process of medicine’s review and subsequent approval by the regulatory authorities in September 2019. This medicine is already approved in the EU for adjunctive therapy of seizures which is associated with Lennox Gastaut syndrome or Dravet syndrome, under the clobazam, for the patients starting from 2 years of age.