Real-World Evidence Sheds Light on SYMPAZAN® Oral Film Use for Lennox-Gastaut Syndrome

Assertio Holdings has announced the results of the first real-world evidence study evaluating patient experience with SYMPAZAN® (clobazam) oral film, presented at the 150th Annual Meeting of the American Neurological Association. According to their website Assertio.com, this research offers valuable insights into how the only FDA-approved oral film formulation of clobazam is being used in daily practice to manage seizures related to Lennox-Gastaut Syndrome (LGS), a severe form of childhood-onset epilepsy.

Understanding SYMPAZAN and LGS

LGS is a rare, debilitating epilepsy syndrome that typically begins in early childhood and affects approximately 50,000 people in the United States. Patients experience challenging, treatment-resistant seizures and may also face cognitive and behavioral difficulties. Managing LGS often requires individualized, evolving approaches over a patient’s lifetime.

SYMPAZAN oral film is indicated as an adjunctive therapy for seizures associated with LGS in patients aged two years and older. The oral film formulation is particularly important for children and others who have difficulty swallowing tablets or liquids, providing a practical alternative that dissolves quickly on the tongue.

Study Design and Key Findings

The study retrospectively analyzed electronic health records from Stanford Health Care covering the years 2015 to 2024. Researchers identified 181 patients with epilepsy, including a subset of 29 individuals diagnosed with LGS, who had been prescribed clobazam oral soluble film. The analysis focused on patient demographics, use of other antiseizure medications, and comorbidities.

Key findings include:

Patients with LGS using SYMPAZAN oral film tended to be younger (average age 13.6 years) compared to the broader epilepsy group (average age 21.1 years).
LGS patients were more likely to have switched from clobazam tablets or liquid suspension to the oral film, highlighting its role for those with swallowing challenges.
Higher rates of cannabidiol use were observed among LGS patients, reflecting the complex, multi-drug regimens often necessary to manage this syndrome.

The data underscore the diversity in patient backgrounds and prescribing patterns, and help illustrate how SYMPAZAN is incorporated into real-world treatment plans for LGS and epilepsy.

Expert Perspectives

Dr. Howard Franklin of Assertio emphasized the significance of these findings, noting that this is the first dataset capturing real-life use of SYMPAZAN in clinical practice for LGS. Dr. Steven Wolf, a study co-author, remarked that such data are crucial for guiding clinicians on the practical incorporation of the oral film into care strategies, especially for patients with unique needs.

Looking Ahead

The study addresses a significant gap in knowledge about the use of clobazam oral film and supports its value for patients who cannot reliably take traditional formulations. As LGS remains a complex and difficult-to-manage disorder, real-world evidence like this can inform better, patient-centered care and help raise awareness of SYMPAZAN as a treatment option.