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

Rhea-AI Summary

Assertio Holdings (NASDAQ: ASRT) presented groundbreaking real-world study data for SYMPAZAN® (clobazam) Oral Film at the 150th Annual Meeting of the American Neurological Association. The study, involving 181 epilepsy patients including 29 with Lennox-Gastaut Syndrome (LGS), marks the first real-world evidence of how the medicine is used in clinical practice.

The research revealed that LGS patients were typically younger (13.6 years vs. 21.1 years in the epilepsy group) and more frequently switched from other clobazam formulations. SYMPAZAN, the only FDA-approved oral film formulation of clobazam, is specifically designed for patients two years and older who have difficulty swallowing tablets or liquids.

Positive

• First-ever real-world study data for SYMPAZAN, providing valuable clinical practice insights
• Demonstrated successful treatment application in patients with swallowing difficulties
• FDA-approved unique oral film formulation addressing specific patient needs

Negative

• None.

Insights

Pharmaceutical Research Analyst

Assertio's first real-world study of SYMPAZAN provides valuable clinical usage data but offers limited commercial implications for ASRT investors.

Assertio has presented the first-ever real-world evidence study for SYMPAZAN (clobazam) oral film, showing how the medication is being utilized in clinical settings for Lennox-Gastaut Syndrome (LGS) patients. The retrospective study analyzed 181 epilepsy patients, including a subset of 29 LGS patients, using electronic health records from Stanford Health Care spanning 2015-2024.

The data reveals several important clinical findings: LGS patients using SYMPAZAN tended to be younger (13.6 vs 21.1 years in the broader epilepsy group), were more likely to have switched from other clobazam formulations, and showed higher cannabidiol use as concomitant therapy.

This study addresses a significant knowledge gap in real-world utilization patterns for SYMPAZAN, which remains the only FDA-approved oral film formulation of clobazam for adjunctive treatment of seizures in LGS patients. The oral film format provides a potentially valuable solution for patients with swallowing difficulties who cannot reliably take tablets or liquid medications—a common challenge in this patient population.

While the study offers valuable clinical insights, its relatively small sample size (particularly the LGS subset) limits broad conclusions. Additionally, as a retrospective analysis from a single health system, the generalizability of these findings requires confirmation through larger, more diverse studies. The poster presentation at the American Neurological Association meeting provides visibility, but more robust data would be needed to significantly influence prescribing patterns or payer decisions.

• 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.

Based on analyses of data collected over a ten-year period, study authors reached the following conclusions.

• In this real-world study of patients with epilepsy or LGS receiving clobazam oral soluble film, patients displayed varying demographics, additional medication use, and comorbidities.
• Patients in the LGS subset tended to be younger in age (13.6 years in the LGS group vs. 21.1 years in the epilepsy group), more often switched from clobazam tablets or suspension, and had higher cannabidiol use than those in the epilepsy group.
• These data provide valuable insights describing patients with epilepsy or LGS and their use of clobazam oral film.
  
  

For additional information about ANA2025, please visit the conference website (click here: https://myana.org/meetings/annual-meeting/).

About Lennox-Gastaut Syndrome
Lennox-Gastaut Syndrome or “LGS” is a severe epilepsy syndrome. LGS is a rare disease, affecting about 50,000 people in the United States. It is generally diagnosed between the ages of three and five, but some people aren’t correctly diagnosed until much later. People with LGS may have many different types of seizures, and some people with LGS also experience cognitive and behavioral challenges. Managing LGS is challenging due to its treatment-resistant seizures and the need for individualized approaches to address evolving symptoms over a patient’s lifetime.

About Assertio
Assertio is a pharmaceutical company with comprehensive commercial capabilities offering differentiated products designed to address patients’ needs. Our focus is on supporting patients by marketing products in oncology, neurology, and pain management. To learn more about Assertio, visit www.assertiotx.com.

About SYMPAZAN Oral Film
SYMPAZAN is the first and only FDA-approved oral film formulation of clobazam, a benzodiazepine approved for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older. SYMPAZAN oral film is berry flavored and offered in 5 mg, 10 mg, and 20 mg dosages consistent with other clobazam formulations.

INDICATIONS AND USAGE
SYMPAZAN^® (clobazam) oral film, CIV is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.

IMPORTANT SAFETY INFORMATION for SYMPAZAN

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

• Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
• The use of benzodiazepines, including SYMPAZAN, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing SYMPAZAN and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.
• Abrupt discontinuation or rapid dosage reduction of SYMPAZAN after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue SYMPAZAN.
  
  

CONTRAINDICATIONS
SYMPAZAN is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients.

WARNINGS AND PRECAUTIONS

Risks from Concomitant Use with Opioids
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe SYMPAZAN concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use. Advise both patients and caregivers about the risks of respiratory depression and sedation when SYMPAZAN is used with opioids.

Abuse, Misuse, and Addiction
Abuse and misuse of benzodiazepines often (but not always) involves the use of doses greater than the maximum recommended dosage and commonly involves concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death.

Use of SYMPAZAN, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of SYMPAZAN along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of Central Nervous System (CNS) depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate.

Dependence and Withdrawal Reactions
Patients at an increased risk of withdrawal reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages and those who have had longer durations of use.

The continued use of benzodiazepines, including SYMPAZAN, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of SYMPAZAN after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures). In some cases, benzodiazepine users have developed protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.

Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants SYMPAZAN has a CNS depressant effect. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol as the effects of other CNS depressants or alcohol may be potentiated.

Somnolence or Sedation SYMPAZAN causes dose-related somnolence and sedation, which generally begins within the first month of treatment and may diminish with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS depressants. Caution patients against engaging in hazardous activities requiring mental alertness, i.e., operating dangerous machinery or motor vehicles, until the effect of SYMPAZAN is known.

Serious Dermatological Reactions Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with clobazam in both children and adults. Discontinue SYMPAZAN at the first sign of rash, unless the rash is clearly not drug-related.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including clobazam. These events can be fatal or life-threatening, particularly if diagnosis and treatment do not occur as early as possible. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement. Eosinophilia is often present. If such signs or symptoms are present, the patient should be evaluated immediately. SYMPAZAN should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including SYMPAZAN, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Neonatal Sedation and Withdrawal Syndrome Use of SYMPAZAN late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to SYMPAZAN during pregnancy or labor for signs of sedation and monitor neonates exposed to SYMPAZAN during pregnancy for signs of withdrawal; manage these neonates accordingly.

ADVERSE REACTIONS
Adverse reactions (≥10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and drooling.

DRUG INTERACTIONS
Opioids: The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of concomitant use of benzodiazepines and opioids and follow patients closely for respiratory depression and sedation.
CNS Depressants and Alcohol: Concomitant use of SYMPAZAN with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence. Caution patients and/or caregivers against simultaneous use with other CNS depressants or alcohol, as effects of other CNS depressants or alcohol may be potentiated.
Hormonal Contraceptives: Hormonal contraceptives that are metabolized by CYP3A4: Effectiveness may be diminished when given with SYMPAZAN. Additional non-hormonal forms of contraception are recommended when using SYMPAZAN.
Drug Metabolized by CYP2D6: SYMPAZAN inhibits CYP2D6, therefore dose adjustment may be necessary of drugs metabolized by CYP2D6 when co-administered with SYMPAZAN.
Strong and Moderate Inhibitors of CYP2C19. Dosage adjustment of SYMPAZAN may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole).
Cannabidiol: Coadministration of cannabidiol and SYMPAZAN may increase the risk of SYMPAZAN-related adverse reactions. Consider dose reduction of cannabidiol or SYMPAZAN should this occur.

USE IN SPECIFIC POPULATIONS

Pregnancy: Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal. Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. Monitor neonates exposed to SYMPAZAN during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, feeding problems, or signs of withdrawal. Manage these neonates accordingly. Encourage pregnant women taking SYMPAZAN to call the toll-free number 1-888-233-2334 to enroll in the Pregnancy Registry or visit https://www.aedpregnancyregistry.org/

Lactation: SYMPAZAN is excreted in human milk. There are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. Infants exposed to SYMPAZAN should be monitored for these effects. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SYMPAZAN^® and any potential adverse effects on the breastfed infant from SYMPAZAN^® or from the underlying maternal condition.

OVERDOSAGE
Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal. Employ general supportive measures, including intravenous fluids and airway maintenance for overdosage management. Flumzenil, a specific benzodiazepine receptor antagonist, can lead to withdrawal and adverse reactions, including seizures. The risk of withdrawal seizures with flumazenil use may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). See the flumazenil injection Prescribing Information. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Please see Full Prescribing Information, including BOXED WARNING and Patient Information at https://www.sympazan.com/pdfs/pi.pdf

To report SUSPECTED ADVERSE REACTIONS, contact Assertio at 1-800-518-1084 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Forward-Looking Statements
Statements in this communication that are not historical facts are forward-looking statements that reflect Assertio’s current expectations, assumptions and estimates of future performance and economic conditions. These forward-looking statements are made in reliance on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, future events or the future performance or operations of Assertio, including risks related to our ability to realize the benefits from our operating model, deliver or execute on our business strategy, including to expand or diversify our asset base and market reach and drive cash flows and growth, successfully integrate new assets, and explore new business development initiatives. All statements other than historical facts may be forward-looking statements and can be identified by words such as “anticipate,” “believe,” “could,” “design,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “imply,” “intend,” “may,” “objective,” “opportunity,” “outlook,” “plan,” “position,” “potential,” “predict,” “project,” “prospective,” “pursue,” “seek,” “should,” “strategy,” “target,” “would,” “will,” “aim” or other similar expressions that convey the uncertainty of future events or outcomes and are used to identify forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond the control of Assertio, including the risks described in Assertio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) and in other filings Assertio makes with the SEC from time to time.

Investors and potential investors are urged not to place undue reliance on forward-looking statements in this communication, which speak only as of this date. While Assertio may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by applicable law.

Contacts
Investors
Matt Kreps, Darrow Associates
+1-214-597-8200 | mkreps@darrowir.com

Media
Michael Blash, BlashComm LLC
+1-215-307-7072 | mblash@assertiotx.com

FAQ

What are the key findings of Assertio's SYMPAZAN real-world study presented at ANA2025?

The study showed that LGS patients using SYMPAZAN were typically younger (13.6 years) compared to the general epilepsy group (21.1 years), with higher rates of switching from other clobazam formulations and increased cannabidiol use.

How many patients were included in Assertio's SYMPAZAN study?

The study included 181 patients with epilepsy, with a subset of 29 patients specifically diagnosed with Lennox-Gastaut Syndrome (LGS).

What is SYMPAZAN used for and who can take it?

SYMPAZAN is the only FDA-approved oral film formulation of clobazam for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients two years of age or older.

When and where was the ASRT SYMPAZAN study conducted?

The study was conducted at Stanford Health Care between 2015 and 2024, using a retrospective, new user cohort study design based on electronic health records.