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26. June 2020
News Pharmaceutical Regulation

UK Government Reclassifies GW Pharma CBD Drug EPIDYOLEX

The UK government has reclassified GW Pharma’s cannabidiol medicine, EPIDYOLEX to the lowest level of control for drugs, clearing the way for improved patient access to the medication.

Under the new scheduling, EPIDYOLEX will become a Schedule 5 drug, which will significantly reduce the administrative burden on organisations providing the drug to patients. The change went into effect on June 24th in all four of the constituent nations of the UK – with Northern Ireland enacting separate legislation.

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, GW’s Chief Operating Officer. “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 ACMD and its Technical Committee recommended the schedule change to Kit Malthouse MP, Minister of State for Crime and Policing, on 29 January 2020. This followed the submission of a written dossier and oral presentation from the MHRA, which drew on the substantial data package developed by GW as part of the medicine’s review and subsequent approval by the regulatory authorities in September 2019.

EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. and the European Medicines Agency’s (EMA) for use in Europe, is an oral solution which contains highly purified cannabidiol (CBD).

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 2 years of age and older.

In its recommendation to the Minister, the ACMD cited the “low risk of abuse potential, low risk of dependency and low risk of diversion” as reasons for the reclassification from a schedule 2 controlled drug to a schedule 5 controlled drug. The ACMD also cautioned that GW’s medicine is “distinct from other commercially available CBD containing supplements that have not sought marketing authorisation as a medicine” and that the schedule change therefore applies exclusively to EPIDYOLEX.

The recommendation was accepted by the Minister on 22 April 2020 and secondary legislation was tabled to enact the change on 3 June 2020.3 GW’s medicine is now exempt from virtually all controlled drug requirements.4 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, thereby potentially reducing travel to hospital pharmacies, whilst healthcare professionals and pharmacists will benefit from reduced controls around the storage and reporting requirements that exist for medicines under Schedule 2.

Source | GW Pharma