SYMPAZAN® (clobazam) oral film from Assertio is used for the adjunctive treatment of seizures associated with LGS in patients two years of age and older
Oral film delivery from SYMPAZAN® delivers clobazam to LGS patients with no crushing, no mixing, no prep work
LAKE FOREST, Ill., Jan. 17, 2023 (GLOBE NEWSWIRE) — Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, today announced that it has provided the LGS Foundation a $100,000 educational grant to assist in efforts to raise awareness of LGS and provide educational materials to the LGS community.
In October, Assertio acquired an exclusive license for SYMPAZAN® (clobazam) oral film CIV, which is approved by the U.S. Food and Drug Administration (FDA) for the adjunctive treatment of seizures associated with LGS in patients two years of age or older.
According to the LGS Foundation, Lennox-Gastaut Syndrome or LGS is a severe epilepsy syndrome. LGS is a rare disease, about 50,000 people in the United States have LGS. It is generally diagnosed between the ages of 3 and 5, but some people aren’t correctly diagnosed until much later. People with LGS may have many different types of seizures, and the condition can be complex to manage. Some people with LGS also experience cognitive and behavioral challenges.
“Assertio is dedicated to being a great partner to the LGS community,” said Dan Peisert, President and Chief Executive Officer of Assertio. “We are very excited to be working with the LGS Foundation to help fund efforts to raise awareness of LGS and to provide educational materials that can benefit LGS patients and their families, friends, caregivers and healthcare providers.”
“Oral film delivery is a beneficial way to deliver medication with consistent dosing,” said Peisert. “These benefits may be particularly important for the delivery of medications to patients diagnosed with LGS who may have difficulty swallowing intact oral dosage forms. In such cases, common methods such as mixing into foods may result in administration challenges. However, we believe that many in the LGS community may not know about SYMPAZAN’s simple and proven effective oral film delivery option for clobazam. We want to ensure that the LGS community is fully aware of their available options so they can have important conversations with their healthcare providers.”
Tracy Dixon-Salazar, Ph.D, Executive Director of the LGS Foundation, said, “We are thrilled to be partnering with Assertio to support our organization’s mission and to help create important new materials for the LGS community. We look forward to a long and collaborative partnership.”
In addition to supporting the LGS Foundation’s educational mission, Assertio will also be joining the organization’s Corporate Advisory Council.
About LGS Foundation
The Lennox-Gastaut Syndrome (LGS) Foundation is a nonprofit organization dedicated to improving the lives of individuals impacted by LGS through advancing research, awareness, education, and family support. For more information, please visit www.lgsfoundation.org
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 2 years of age or older. SYMPAZAN oral film is berry flavored and offered in 5 mg, 10 mg, and 20 mg dosages to meet a range of LGS patient and caregiver needs.
Assertio is a specialty pharmaceutical company offering differentiated products to patients utilizing a non-personal promotional model. We have built and continue to build our commercial portfolio by identifying new opportunities within our existing products as well as acquisitions or licensing of additional approved products. To learn more about Assertio, visit www.assertiotx.com.
INDICATIONS AND USAGE
SYMPAZAN® 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.
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 ONFI 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.
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.
Adverse reactions (≥10% and more frequently than placebo) included constipation, somnolence or sedation, pyrexia, lethargy, and drooling.
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: SYMPAZAN may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, withdrawal syndrome and symptoms suggestive of floppy infant syndrome. Encourage patients to call the toll-free number 1-888-233-2334 to enroll in the Pregnancy Registry or visit http://www.aedpregnancyregistry.org/
Lactation: SYMPAZAN is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from SYMPAZAN, discontinue nursing or discontinue the drug.
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 Therapeutics 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 our ability to realize the benefits from our operating model, successfully acquire and integrate new assets including Sympazan 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. Nothing contained herein constitutes or will be deemed to constitute a forecast, projection or estimate of the future financial performance or expected results of Assertio.