Assertio Presents First-Ever Real-World Study Showing Patient Experience with SYMPAZAN (clobazam) Oral Film, CIV

• New data show how Sympazan is being used in daily clinical practice to treat patients with Lennox-Gastaut Syndrome (LGS), a severe form of childhood-onset epilepsy
• Study addresses lack of awareness and real-world data with oral film formulation of clobazam
• New data presented during poster session at 150^th Annual Meeting of the American Neurological Association
• 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

BALTIMORE, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs, today announced new data from a first-ever real-world study of SYMPAZAN (clobazam) Oral Film.

The data were presented at the 150^th Annual Meeting of the American Neurological Association (ANA2025) as a poster (click here for poster) titled “M266: Real-World Evidence Study of Patients with Lennox-Gastaut Syndrome Taking Clobazam Oral Soluble Film: Demographics, Medications, and Comorbidities.”

Howard Franklin, M.D., Senior Vice President of Medical with Assertio: "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., Department of Pediatric Neurology, Boston Children’s Health Physicians, Department of Neurology, Westchester Medical Center, Valhalla, NY, and a study author: “Clobazam can be an important treatment for LGS patients, which is a severe form of childhood-onset epilepsy that can be debilitating. This study allows the medical community to view real-world data about utilization of the oral film formulation offered by Sympazan and can help clinicians better understand how to incorporate the medicine in treatment regimens.”

Study Design and Conclusions
The study’s objective was to report real-world demographics, concomitant antiseizure medication use, and comorbidities in patients with epilepsy or LGS previously treated with clobazam oral soluble film. Overall, 181 patients with epilepsy and a subset of 29 patients with LGS were identified. Sympazan (clobazam) oral film is approved only for the adjunctive treatment of seizures associated with LGS in patients two years of age and older. Study authors conducted a retrospective, new user cohort study using electronic health records collected during routine care at Stanford Health Care between 2015 and 2024. Patients were identified based on diagnoses for epilepsy or LGS, with information from health records of patients taking clobazam oral soluble film, including patient demographics, antiseizure medication use, and comorbidities.