Jazz Pharmaceuticals Showcasing Long-Term and Real-World Data on Treatment-Resistant Epilepsy at 2023 American Epilepsy Society Annual Meeting

Taking place at the 2023 American Epilepsy Society (AES) annual meeting, Jazz Pharmaceuticals, a global biopharmaceutical company, disclosed that there will be nine company-sponsored presentations which include five late-breaking abstracts covering Epidiolex® data in a recent press release (1). The meeting will be taking place in Orlando, Florida, on December 1-5, 2023.

Epidiolex® (cannabidiol [CBD]) is a drug used for treatment-resistant epilepsy such as those seen in patients who have Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) (1). Presentations at AES will showcase long-term and real-world results from the Expanded Access Program (EAP), GWPCARE6 Open-Label Extension (OLE) trial, the BECOME-TSC (BEhavior, COgnition, and More with Epidiolex) (tuberous sclerosis complex [TSC]), and more (1).

"Multiple presentations at the 2023 AES meeting continue to build the scientific evidence in support of Epidiolex and improve understanding around the treatment's full impact," Kelvin Tan, MBBCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals mentioned (1). "In addition to seizure outcomes, the BECOME studies are also designed to assess non-seizure benefits of Epidiolex, such as cognition and executive function, emotional and social function, and language and communication. We are determined to not only address seizure outcomes for patients living with rare epilepsies, but also improve the day-to-day lives for both patients and their loved ones."

In Jazz Pharmaceuticals press release, they announced a few of the data highlights which will be shared during the meeting (1):

• A post-hoc analysis of patients diagnosed with treatment-resistant focal epilepsy within the EAP that demonstrated Epidiolex was associated with a sustained reduction in focal-onset seizures through 144 weeks. Notably, a second post-hoc analysis investigated the effectiveness and safety results of Epidiolex in adult patients from the EAP which found similar outcomes among patients with treatment-resistant epilepsies, including focal seizures. The EAP was an initiative launched in 2014 to provide add-on Epidiolex to patients with treatment-resistant epilepsy at 35 U.S. epilepsy centers.
• A post-hoc analysis of the GWPCARE6 OLE trial evaluating the effectiveness of Epidiolex as add-on therapy against focal seizures in TSC. At least 50% reduction was reported by the majority of patients across focal seizure types through 144 weeks. Additionally, responder rates for focal seizure subtypes were consistent with the overall focal seizure responder rates, and the safety profile observed in the analysis was consistent with that observed in its overall clinical development program.
• Interim results of the BECOME-TSC survey, in which the majority of caregivers reported patient improvements in overall seizure frequency and severity, as well as improvements in patients' cognition, emotional functioning, and communication domains.

To view the AES abstracts, please visit (2): https://aesnet.org/education/annual-meeting/aes-abstract-search.

References

1. Jazz Pharmaceuticals. Jazz Pharmaceuticals to Present Long-Term and Real-World Data Emphasizing Commitment to Treatment-Resistant Epilepsy at the 2023 American Epilepsy Society Annual Meeting https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-to-present-long-term-and-real-world-data-emphasizing-commitment-to-treatment-resistant-epilepsy-at-the-2023-american-epilepsy-society-annual-meeting-302002714.html (accessed Dec 4, 2023).
2. Abstract Search https://www.aesnet.org/education/annual-meeting/aes-abstract-search (accessed Dec 4, 2023).