Jazz Pharmaceuticals plc announced that eight abstracts, including four that are late-breaking, will be presented on Epidiolex®? (cannabidiol) at the American Epilepsy Society (AES) 2025 Annual Meeting, being held December 5-9, 2025, in Atlanta, Georgia. Notable data include new results from the EpiCom trial, an ongoing Phase 3b/4 study evaluating behavioral and other non-seizure outcomes after initiation of adjunctive Epidiolex treatment in participants with tuberous sclerosis complex (TSC)-associated seizures.
Additional highlights at AES 2025 include: A late-breaking poster featuring results from a Phase 1 clinical study evaluating bidirectional pharmacokinetic (PK) drug-drug interactions between Epidiolex and cenobamate, which did not find PK interactions between cannabidiol and cenobamate parent molecules when concomitantly administered at clinically relevant dosages. A late-breaking poster showcasing preclinical data that demonstrates a novel synergistic pharmacodynamic interaction between Epidiolex and Cenobamate in effectiveness in the mouse maximal electroshock seizure model of acute generalized seizures. The other poster highlights data that indicates Epidiolex initiation also reduces antiseizure medication cycling at 12 months, as well as decreased polypharmacy and HRU in both pediatric and adult patients.
A poster presentation featuring post-hoc analysis from the Expanded Access Program demonstrates Epidiolex treatment is associated with reductions in convulsive and total seizure frequency in patients with developmental and epileptic encephalopathies (DEEs) and rare epilepsy syndromes. The comparative effectiveness analysis confirms the superiority of Epidiolex in reducing seizure frequency from baseline compared to an external placebo control arm. A poster presentation highlighting a subgroup analysis of Epidiolex pivotal clinical trial data showing participants with Lennox-Gastaut syndrome (LGS) diagnoses, which are secondary to a genetic DEE, experienced consistent efficacy and safety as compared to the overall LGS pivotal trial populations.
A late-breaking poster presentation on data from the Epilepsy Learning Healthcare System (ELHS), an Epilepsy Foundation-sponsored initiative, highlights its potential to provide real-world treatment insights beyond clinical trials and claims data. The precise mechanisms by which Epidiolex exerts its anticonvulsant effect in humans are unknown. Epidiolex was approved by the U.S. Food and Drug Administration (FDA) for use in the U.S., the European Commission (EC) for use in Europe, the Medicines and Healthcare products Regulatory Agency (MHRA) for use in Great Britain, the Therapeutic Goods Administration for use in Australia, Swissmedic for use in Switzerland, the Food & Nutrition Services of the Israel Ministry of Health for use in Israel, and the New Zealand Medicines and Medical Devices Safety Authority for use in New Zealand, is an oral solution which contains highly purified cannabidiol (CBD).
In the U.S., Epidiolex is indicated for the treatment of seizures associated with Lennox-Gast Aut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex has received approval in the European Union under the tradename Epidyolex for use in the European Union under the Tradename Epidyolex for the treatment of seizures.
