Assertio Holdings, Inc. (“Assertio” or the “Company”) (Nasdaq:
ASRT), a specialty pharmaceutical company, today announced that it
is providing educational grant funding for the Lennox-Gastaut
Syndrome (LGS) Foundation’s new About LGS Treatments
for families coping with LGS. Assertio markets
SYMPAZAN® (clobazam) oral film CIV, approved by the U.S. Food
and Drug Administration (FDA) for the adjunctive treatment of
seizures associated with LGS in patients aged two years of age or
Assertio announced in December that it provided a $100,000
educational grant to the LGS Foundation.
“Assertio is proud to support the LGS community,” said Dan
Peisert, President and Chief Executive Officer of Assertio. “Our
focus is on working with the LGS Foundation to help raise awareness
of LGS and to support development of educational materials that can
benefit their community.”
Tracy Dixon-Salazar, Ph.D, Executive Director of the LGS
Foundation, said the kits will include information about
medications to treat seizures associated with LGS, diet therapy,
neuromodulatory treatments, epilepsy surgery, and much more.
“I wish I had a kit like this when my daughter was first
diagnosed with LGS over two decades ago,” said Dr. Dixon-Salazar.
“Our community has told us that they need more information to help
them understand their options for treatment of seizures in LGS.
This kit will help do just that.”
Dr. Dixon-Salazar said the Treatment Kits will be provided
starting today to any family requesting one. Families impacted by
Lennox-Gastaut Syndrome can request an About LGS Treatments Kit on
the LGS Foundation’s website.
About LGS FoundationThe 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.
About SympazanSYMPAZAN 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
About Assertio 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 USAGESYMPAZAN® (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
• 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
SYMPAZAN is contraindicated in patients with a history of
hypersensitivity to the drug or its ingredients.
WARNINGS AND PRECAUTIONS
Risks from Concomitant Use with
OpioidsObservational 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 AddictionAbuse 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 ReactionsPatients 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 fi rst 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
Adverse reactions (≥10% and more frequently than placebo)
included constipation, somnolence or sedation, pyrexia, lethargy,
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
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
Please see Full Prescribing Information, including BOXED
WARNING and Patient Information at
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
Investor Contact Matt KrepsManaging
DirectorDarrow AssociatesAustin, TX M:
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