New data shows Sympazan usage in daily practice for Lennox-Gastaut Syndrome.

Assertio Holdings presented new data on the use of Sympazan, an oral film formulation of clobazam, in treating Lennox-Gastaut Syndrome (LGS), a severe form of childhood-onset epilepsy. The data showed how Sympazan is being used in daily clinical practice to treat patients with LGS. Sympazan is the only FDA-approved oral film formulation of clobazam for adjunctive treatment of seizures associated with LGS in patients two years of age or older. The study addressed the lack of awareness and real-world data for oral film formulations of clobazam.

Assertio Holdings, Inc. (Nasdaq: ASRT) has released new data on the real-world use of SYMPAZAN (clobazam) oral film in the treatment of Lennox-Gastaut Syndrome (LGS), a severe form of childhood-onset epilepsy. The data, presented at the 150th Annual Meeting of the American Neurological Association (ANA2025), offer insights into how SYMPAZAN is being utilized in daily clinical practice to treat patients with LGS.

SYMPAZAN is the only FDA-approved oral film formulation of clobazam for the adjunctive treatment of seizures associated with LGS in patients two years of age or older. The study, titled "M266: Real-World Evidence Study of Patients with Lennox-Gastaut Syndrome Taking Clobazam Oral Soluble Film: Demographics, Medications, and Comorbidities," addressed the lack of awareness and real-world data regarding oral film formulations of clobazam.

The study, conducted using electronic health records from Stanford Health Care between 2015 and 2024, identified 181 patients with epilepsy and 29 patients with LGS who were previously treated with clobazam oral soluble film. The data revealed varying demographics, concomitant antiseizure medication use, and comorbidities among the patients.

Key findings include:
- Patients in the LGS subset tended to be younger (13.6 years) compared to the epilepsy group (21.1 years).
- A higher proportion of LGS patients switched from clobazam tablets or suspension.
- LGS patients also had higher cannabidiol use than those in the epilepsy group.

The study highlights the value of SYMPAZAN in addressing the treatment challenges of LGS, particularly for patients with swallowing difficulties who cannot reliably take tablets or liquids. The findings support the role of an oral film formulation in treating LGS patients and can help clinicians better understand how to incorporate SYMPAZAN into treatment regimens.

Assertio's Senior Vice President of Medical, Howard Franklin, M.D., stated, "This is the first data of its kind for Sympazan, showing how this medicine is being applied in daily clinical practice to treat patients with seizures associated with LGS. The findings support the role that an oral film formulation can play in treating LGS patients who have swallowing difficulties and cannot reliably take tablets or liquids."

Steven M. Wolf, M.D., a study author, emphasized the importance of the study in providing real-world data about the utilization of the oral film formulation offered by SYMPAZAN. He noted that clobazam can be an important treatment for LGS patients, which is a severe form of childhood-onset epilepsy that can be debilitating.

The study underscores the potential of SYMPAZAN in improving the quality of life for patients with LGS by providing a more accessible and effective treatment option. The data presented at ANA2025 are a significant contribution to the understanding of LGS treatment and the role of oral film formulations in addressing the unique challenges of this condition.