GW Pharma Makes Big Regulatory Step for Cannabidiol in UK

Health and Healthcare

Published: June 24, 2020 9:59 am

GW Pharmaceuticals PLC (NASDAQ: GWPH) took a big step forward for the development of its cannabidiol in the United Kingdom. The company announced that the U.K. Home Office has reclassified Epidyolex (cannabidiol) as a Schedule 5 drug.

This change will take effect immediately in all four of the constituent nations of the United Kingdom (with Northern Ireland enacting separate legislation) and sees the medicine move from Schedule 2 to Schedule 5 under the Misuse of Drugs Regulations 2001.

The medicine is approved in the European Union 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 schedule change was recommended by the Advisory Council on the Misuse of Drugs (ACMD) and its Technical Committee to Kit Malthouse MP, Minister of State for Crime and Policing, on January 29, 2020. This followed the submission of a written dossier and oral presentation from the Medicines and Healthcare Regulatory Agency, 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.

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.

As a result, GW’s medicine is now exempt from virtually all controlled drug requirements.

GW Pharmaceuticals stock traded relatively flat at $125.04 Wednesday morning, in a 52-week range of $67.98 to $180.75. The consensus price target is $188.63.