GW Pharmaceuticals plc presented a variety of data on cannabidiol oral solution (CBD) at the 13th Annual European Congress of Epileptology (ECE), which took place in Vienna, Austria from 26-30 August 2018.
The studies provide additional insight into the safety and efficacy of GW’s CBD oral solution in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two rare and severe forms of childhood-onset epilepsy that are highly treatment-resistant1,2. In addition, data related to the pharmacology of CBD, and its antiseizure properties, will provide additional understanding of CBD’s role in the management of such diseases. A marketing authorisation application for GW’s CBD oral solution is currently under review by the European Medicines Agency (EMA).
“GW is proud to be presenting a wealth of data on its CBD oral solution to the epilepsy community. Our comprehensive pre-clinical and clinical programmes provide an understanding of the way in which CBD exhibits anti-seizure effects and further supports its efficacy and tolerability profile in patients living with two of the most difficult-to-treat forms of epilepsy,” stated Justin Gover, GW’s Chief Executive Officer. “There is still a huge unmet medical need for effective medicines that help people suffering from severe forms of treatment resistant epilepsy, and we believe that our CBD oral solution may present an important new therapeutic option in the future.”
CBD data highlights:
Highlights include the presentation of pooled efficacy and safety data from two phase III randomised placebo-controlled trials of CBD in LGS, Phase 1 drug-drug interaction data on the co-administration of CBD and clobazam, and the potential role of GPR55 and the TRPV1 receptor-dependent interaction in the anti-epileptic properties of CBD.
The full list of GW titles presented is as follows:
- Cannabidiol (CBD) Significantly Reduces Drop Seizure Frequency in Lennox-Gastaut Syndrome (LGS): Pooled Efficacy and Safety Results from 2 Randomized, Controlled Trials
- Bidirectional Drug-drug Interaction with coadministration of Cannabidiol and Clobazam in a Phase 1 Healthy Volunteer Trial
- Maintained Safety and Efficacy of Cannabidiol (CBD) in a Long-Term Open-Label Trial in Patients with Lennox-Gastaut Syndrome (LGS) (GWPCARE 5)
- Exposure-Response Analysis of Cannabidiol Oral Solution for the Treatment of Lennox–Gastaut SyndromeA Phase 2 Trial to Explore the Potential for a Pharmacokinetic Drug-drug Interaction with Valproate when in Combination with Cannabidiol in Adult Epilepsy Patients (late breaking abstract)
- Antiseizure properties of CBD are attenuated in the absence of TRPV1 receptors
- A role of GPR55 in the anti-epileptic properties of cannabidiol
- Maintenance of Long-Term Safety and Efficacy of Cannabidiol (CBD) Treatment in Dravet Syndrome (DS): Results of the Open-Label Extension (OLE) Trial (GWPCARE 5)
- Bidirectional Drug-drug Interactions with Co-administration of Cannabidiol and Stiripentol or Valproate in a Phase 1 Healthy Volunteer Trial