SYMPAZAN Shows Promise in Real-World Treatment of Childhood Epilepsy: What the New Research Reveals

Assertio Holdings revealed groundbreaking real-world evidence regarding how SYMPAZAN (clobazam) oral film is being utilized in clinical settings for managing Lennox-Gastaut Syndrome (LGS), a severe form of childhood-onset epilepsy. The findings, unveiled at the 150th Annual Meeting of the American Neurological Association in September 2025, mark the first comprehensive real-world data on the oral film formulation of this seizure medication.

Understanding the Research Findings

The retrospective study analyzed electronic health records from Stanford Health Care spanning 2015 to 2024, identifying 181 patients with epilepsy and a subset of 29 specifically diagnosed with LGS who had received clobazam oral soluble film treatment. Key discoveries included significant differences in patient demographics between the LGS-specific group and the broader epilepsy cohort.

Children with LGS proved notably younger, averaging 13.6 years compared to 21.1 years in the general epilepsy group. A substantial proportion of LGS patients had transitioned from tablet or suspension formulations to the oral film version. Additionally, cannabidiol usage was substantially higher among the LGS subset, reflecting evolving treatment approaches for this complex condition.

Why Oral Film Formulation Matters

SYMPAZAN distinguishes itself as the only FDA-approved oral film formulation of clobazam available for adjunctive seizure treatment in LGS patients aged two years and older. This formulation addresses a critical clinical gap: many young patients with swallowing difficulties cannot reliably tolerate tablets or liquid medications. The berry-flavored film comes in 5 mg, 10 mg, and 20 mg dosages, offering flexibility comparable to other clobazam preparations.

Dr. Steven M. Wolf, Department of Pediatric Neurology at Boston Children’s Health Physicians, emphasized the clinical significance: “This study allows the medical community to view real-world data about utilization of the oral film formulation and can help clinicians better understand how to incorporate the medicine in treatment regimens” for a condition that remains challenging to manage due to treatment-resistant seizures.

The LGS Challenge

Lennox-Gastaut Syndrome affects approximately 50,000 people in the United States, typically diagnosed between ages three and five, though some receive diagnoses much later. This rare epilepsy syndrome frequently involves multiple seizure types and can produce cognitive and behavioral complications. Managing LGS demands individualized approaches that evolve throughout a patient’s lifetime.

Critical Safety Considerations

SYMPAZAN carries important warnings regarding concomitant use with opioids, as combined therapy can result in profound sedation, respiratory depression, and potentially fatal outcomes. The medication poses risks of dependence and withdrawal reactions if discontinued abruptly or dosage reduced rapidly. Users should avoid simultaneous use with other central nervous system depressants or alcohol.

Common adverse reactions observed at frequencies ≥10% and exceeding placebo include constipation, somnolence or sedation, pyrexia, lethargy, and drooling. Serious dermatological reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported, requiring immediate discontinuation at first signs of rash unless clearly unrelated to the medication.

Drug Interactions and Special Populations

SYMPAZAN inhibits CYP2D6, potentially requiring dosage adjustments for medications metabolized through this pathway. Coadministration with strong or moderate CYP2C19 inhibitors may necessitate SYMPAZAN dosage modification. Importantly, hormonal contraceptives metabolized by CYP3A4 may experience diminished effectiveness, warranting additional non-hormonal contraception methods.

Pregnant women taking SYMPAZAN should be aware that benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. The medication is excreted in human milk, with reports of sedation and poor feeding in breastfed infants exposed to benzodiazepines.

Looking Forward

This inaugural real-world evidence study provides valuable insights into SYMPAZAN usage patterns and patient demographics, supporting clinicians in optimizing treatment strategies for this challenging epilepsy subtype. As the only oral film formulation of clobazam approved by the FDA for LGS management, SYMPAZAN continues establishing its role in addressing the specific needs of pediatric patients who require seizure management without the barriers presented by traditional tablet or liquid formulations.

For additional information about SYMPAZAN or to report suspected adverse reactions, contact Assertio at 1-800-518-1084 or the FDA at 1-800-FDA-1088.