CONTACT:

Elizabeth Likly
Kovak-Likly Communications
203-762-8833, elikly@klcpr.com

FOR IMMEDIATE RELEASEUPSHER-SMITH LABORATORIES LAUNCHES TOSYMRA™ (SUMATRIPTAN) NASALSPRAY FOR THE ACUTE TREATMENT OF MIGRAINE IN ADULTS
Delivers the Efficacy of an Injectable with the Convenience of a Nasal Spray
Maple Grove, MN – October 2, 2019 – Upsher-Smith Laboratories, LLC (Upsher-Smith)
today announced the launch of Tosymra™ (sumatriptan) Nasal Spray, 10 mg for the acutetreatment of migraine with or without aura in adults. Tosymra is a fast-acting, easy-to-use acutemigraine treatment option that delivers the efficacy of an injectable in a convenient nasal spray.
Tosymra, which was approved by the U.S. Food and Drug Administration in early 2019, wasrecently acquired by Upsher-Smith from Dr. Reddy’s Laboratories Limited in a strategic effort toexpand and diversify the Company’s migraine portfolio.
Tosymra is supported by Upsher-Smith’s Access Pathways® Program, which provides
savings and support services for patients. The Platinum Pass® savings card enables
commercially insured patients to pay as little as $0 per prescription.*“We’re excited to launch Tosymra, the third product in Upsher-Smith’s growing migraine
portfolio, which includes Qudexy® XR and Zembrace® SymTouch®,” said Rusty Field, President
and CEO, Upsher-Smith. “Many patients face challenges during migraine attacks that makeavailable acute treatment options inadequate. Tosymra Nasal Spray offers an alternative forpatients whose symptoms interfere with taking oral medication or who may be dissatisfied with
their current treatment regimen.”
Tosymra, which utilizes Intravail® technology, efficiently delivers sumatriptan intranasallyand achieves median peak plasma concentration five minutes faster than injectable
sumatriptan, 4 mg and 6 mg. Additionally, in the two hours following administration, a 10-mg
dose of Tosymra demonstrated a markedly increased rate and extent of sumatriptan absorption
when compared with Imitrex® 20-mg nasal spray**.
More than 36 million patients suffer from migraines and surveys have shown that a majority
are willing to try other acute treatment options.1 Patients currently using oral treatment options

may face challenges including nausea and gastroparesis or vomiting which may delay or limit
oral medication absorption.
Important Patient Safety Information for Tosymra™ (sumatriptan) Nasal Spray
What important information should I know about TOSYMRA?
TOSYMRA can cause serious side effects, including: heart attack and other heart
problems, which may lead to death. Stop using TOSYMRA and get emergency
medical help right away if you have any of the following symptoms of a heart attack:

•
•
•
•
•
•
•

discomfort in the center of your chest that lasts for more than a few minutes, or that
goes away and comes backsevere tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

TOSYMRA is not for people with risk factors for heart disease (high blood pressure,high cholesterol levels, smoking, overweight, diabetes, family history of heart disease)
unless a heart exam is done and shows no problem.
Who should not use TOSYMRA?
Do not use TOSYMRA if you have:• heart problems or a history of heart problems• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vasculardisease)• uncontrolled high blood pressure• severe liver problems• hemiplegic migraines or basilar migraines. If you are not sure if you havethese, ask your healthcare provider• had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation• taken any of the following medicines in the last 24 hours: almotriptan,
eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, ordihydroergotamine. Ask your healthcare provider if you are not sure if
your medicine is listed above• are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors
or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask yourhealthcare provider or pharmacist for a list of these medicines if you are not sure.
• an allergy to sumatriptan or any of the ingredients in TOSYMRA.
What should I tell my healthcare provider before taking TOSYMRA?
Tell your healthcare provider about all of your medical conditions, and about all the medicines
you take, including prescription and over-the-counter medicines, vitamins, and herbal

supplements.
What should I avoid while using TOSYMRA?
TOSYMRA can cause dizziness, weakness, or drowsiness. If you have these symptoms, do
not drive a car, use machinery, or do anything where you need to be alert.
What are possible side effects of TOSYMRA?
TOSYMRA may cause serious side effects including:• changes in color or sensation in your fingers and toes (Raynaud’s syndrome)• stomach and intestinal problems (gastrointestinal and colonic ischemic events).
Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe
stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation
or diarrhea, bloody diarrhea, fever• problems with blood circulation to your legs and feet (peripheral vascular ischemia).
Symptoms of peripheral vascular ischemia include: cramping and pain in your legs or
hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in yourfeet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling orcolor changes in 1 or both legs or feet
• Increased blood pressure including a sudden severe increase (hypertensive crisis) even
if you have no history of high blood pressure• medication overuse headaches. Some people who use too much migraine
medicine, such as TOSYMRA, for 10 or more days each month may have worse
headaches (medication overuse headache). If your headaches get worse, yourhealthcare provider may decide to stop yourtreatment with TOSYMRA.
• serotonin syndrome. Serotonin syndrome is a rare but serious problem that canhappen in people using TOSYMRA, especially if TOSYMRA is used with antidepressant medicines called SSRIs or SNRIs.
o Call your healthcare provider right away if you have any of the following
symptoms of serotonin syndrome: mental changes such as seeing things thatare not there (hallucinations), agitation, or coma; fast heartbeat; changes in bloodpressure; high body temperature; tight muscles; or trouble walking••

hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures have happened in people taking sumatriptan who have never had seizures before

The most common side effects of TOSYMRA include: tingling, dizziness, feelingwarm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling oftightness, numbness, application site (nasal) reactions, abnormal taste, and throat
irritation.
Tell your healthcare provider if you have any side effect that bothers you or that does not
go away. These are not all the possible side effects of TOSYMRA. For more information,
ask your healthcare provider or pharmacist.
This is the most important information to know about TOSYMRA but is not comprehensive. For
more information, talk to your healthcare provider and read the Patient Information andInstructions for Use for TOSYMRA. You can also visit www.upsher-smith.com or call 1-888650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
What is TOSYMRA used for?
TOSYMRA is a prescription medicine used to treat acute migraine headaches with orwithout aura in adults.
TOSYMRA is not used to treat other types of headaches such as hemiplegic (that make you
unable to move on one side of your body) or basilar (rare form of migraine with aura)
migraines. TOSYMRA is not used to treat cluster headaches.
TOSYMRA is not used to prevent or decrease the number of migraines you have. It is notknown if TOSYMRA is safe and effective in children under 18 years of age.
Important Patient Safety Information for Zembrace® SymTouch®
What important information should I know about ZEMBRACE SymTouch?
ZEMBRACE SymTouch can cause serious side effects, including: heart attack andother heart problems, which may lead to death. Stop using ZEMBRACE SymTouchand get emergency medical help right away if you have any of the following
symptoms of a heart attack:• discomfort in the center of your chest that lasts for more than a few minutes, or
•
•
•
•
•

that goes away and comes backsevere tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach shortness of breath
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

ZEMBRACE SymTouch is not for people with risk factors for heart disease (high bloodpressure, high cholesterol levels, smoking, overweight, diabetes, family history of heartdisease) unless a heart exam is done and shows no problem.
Who should not use ZEMBRACE SymTouch?
Do not use ZEMBRACE SymTouch if you have:• heart problems or a history of heart problems• had a stroke, transient ischemic attacks (TIAs), or problems with your••••blood circulation
narrowing of blood vessels to your legs or arms (peripheral vasculardisease), stomach, or kidney
uncontrolled high blood pressure
hemiplegic migraines (that make you unable to move on one side of your body)or basilar (rare form of migraine with aura) migraines. If you are not sure if you
have these, ask your healthcare provider
taken any of the following medicines in the last 24 hours: almotriptan,
eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, ordihydroergotamine. Ask your healthcare provider if you are not sure if your

medicine is listed above• severe liver problems• an allergy to sumatriptan or any of the components of ZEMBRACE SymTouch
What should I tell my healthcare provider before taking ZEMBRACE SymTouch?
Tell your healthcare provider about all of your medical conditions and about all the
medicines you take, including prescription and over-the-counter medicines, vitamins, andherbal supplements.
What should I avoid while using ZEMBRACE SymTouch?
ZEMBRACE SymTouch can cause dizziness, weakness, or drowsiness. If you have these
symptoms, do not drive a car, use machinery, or do anything where you need to be alert.
What are possible side effects of ZEMBRACE SymTouch?
ZEMBRACE SymTouch may cause serious side effects including:

•
•
•
•
•

changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
stomach and intestinal problems (gastrointestinal and colonic ischemic events)
problems with blood circulation to your legs and feet (peripheral vascular ischemia)
hives (itchy bumps); swelling of your tongue, mouth, or throat
medication overuse headaches. Some people who use too manyZEMBRACE SymTouch injections may have worse headaches (medication
overuse headache)• serotonin syndrome. Serotonin syndrome is a rare but serious problem that canhappen in people using ZEMBRACE SymTouch, especially if used withantidepressant medicineso Call your healthcare provider right away if you have any of thefollowing symptoms of serotonin syndrome: mental changes such as
seeing things that are not there (hallucinations), agitation, or coma; fastheartbeat; changes in blood pressure; high body temperature; tightmuscles; trouble walking; or nausea, vomiting, or diarrhea• serious allergic reactions. Get medical help right away if you have any of these
symptoms of a serious allergic reaction: swelling of your face, lips, mouth, or
tongue; trouble breathing; wheezing; severe itching; skin rash, redness, or
swelling; dizziness or fainting; fast heartbeat or pounding in your chest; orsweating• Seizures have happened in people taking sumatriptan who have never had
seizures before
The most common side effects of ZEMBRACE SymTouch include pain and redness at
your injection site; tingling or numbness in your fingers or toes; dizziness; warm, hot, burning
feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or
tired.
This is the most important information to know about ZEMBRACE SymTouch but is notcomprehensive. For more information, talk to your healthcare provider and read the Patient
Information and Instructions for Use for ZEMBRACE SymTouch. You can also
visit www.upsher-smith.com or call 1-888-650-3789.
You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
INDICATION AND USAGE
What is ZEMBRACE SymTouch used for?
ZEMBRACE SymTouch is a prescription medicine used to treat acute migraine headacheswith or without aura in adults who have been diagnosed with migraine.
ZEMBRACE SymTouch is not used to prevent or decrease the number of migraines you have.
It is not known if ZEMBRACE SymTouch is safe and effective in children under 18 years ofage.
Please see Patient Information, Instructions For Use and Full Prescribing Information
for ZEMBRACE SymTouch or visit www.zembrace.com.
Important Patient Safety Information for Qudexy® XR (topiramate) Extended-Release
Capsules
WHAT IS QUDEXY XR?
Qudexy® XR (topiramate) Extended-Release Capsules is a prescription medicine used:• To prevent migraine headaches in adults and adolescents 12 years and older.
• To treat certain types of seizures (partial-onset seizures and primary generalized tonicclonic seizures) in adults and children 2 years and older.
• With other medicines to treat certain types of seizures (partial-onset seizures, primary
generalized tonic-clonic seizures, and seizures associated with Lennox-Gastautsyndrome) in adults and children 2 years and older.
WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW?
Qudexy XR can cause serious side effects, including: Serious eye problems, which may include blurred or sudden decrease in vision, eye pain
and redness or a blockage of fluid that may cause increased pressure in the eye (secondary
angle closure glaucoma). If left untreated, this can lead to permanent vision loss.
 Decreased sweating and fever. People, especially children, should be watched for signs ofdecreased sweating and fever, especially in hot temperatures. Some people may need to behospitalized for this condition.
 Increased acid level in the blood (metabolic acidosis). This may or may not cause
symptoms. Symptoms may include feeling tired, decreased appetite, change in heartbeat, or
trouble thinking clearly. If left untreated, metabolic acidosis can cause brittle or soft bones(osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth inchildren, and may possibly harm the unborn child of pregnant patients.
 High blood ammonia levels. High ammonia in the blood can affect mental activities, slow
alertness and cause tiredness or vomiting. This can also happen when Qudexy XR is takenwith a medicine called valproic acid (e.g., Depakene® and Depakote®).
 Kidney stones. Drink plenty of fluids when taking Qudexy XR to decrease your chances ofgetting kidney stones.
 Low body temperature. Taking Qudexy XR when you are also taking valproic acid may
cause a drop in body temperature to less than 95°F, tiredness, confusion, or coma.



Effects on thinking and alertness. Qudexy XR may affect how you think, and can cause
confusion, problems with concentration, attention, memory, or speech. Qudexy XR may
cause depression or mood problems, tiredness, and sleepiness.
Dizziness or loss of muscle coordination.
Call your healthcare provider right away if you have any of the above symptoms.

Like other antiepileptic drugs, Qudexy XR may cause suicidal thoughts or actions in avery small number of people, about 1 in 500. Before taking Qudexy XR, tell your healthcare
provider if you have or have had depression, mood problems, or suicidal thoughts or behavior.
Call a healthcare provider right away if you have: thoughts about suicide or dying; attempt tocommit suicide; have new or worsening depression or anxiety; feel agitated or restless;experience panic attacks, have trouble sleeping (insomnia); have new or worsening irritability;
feel or act aggressive, angry, or violent; act on dangerous impulses; experience an extreme
increase in activity and talking (mania); or other unusual changes in your behavior or mood.
Qudexy XR can harm your unborn baby. All women of childbearing age should talk to theirhealthcare provider about possible alternative treatments. If you take Qudexy XR during
pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These
defects can begin early in pregnancy, even before you know you are pregnant. Also, if you take
Qudexy XR during pregnancy, your baby may be smaller than expected at birth; the long-term
effects of this are not known. If the decision is made to use Qudexy XR, you should use
effective birth control (contraception).Tell your healthcare provider right away if you
become, or plan to become pregnant while taking Qudexy XR.
The most common side effects of Qudexy XR include: tingling of the arms and legs(paresthesia), not feeling hungry, weight loss, nervousness, nausea, speech problems,
tiredness, dizziness, sleepiness/drowsiness, a change in the way foods taste, upper respiratory
tract infection, decreased feeling or sensitivity especially in the skin, slow reactions, difficultywith memory, fever, abnormal vision, diarrhea, and pain in the abdomen. These are not all thepossible side effects of Qudexy XR. For more information, ask your healthcare provider or
pharmacist.
Before taking Qudexy XR, tell your healthcare provider about all of your medical
conditions, including if you: have had depression, mood problems, or suicidal thoughts or
behavior; have kidney problems, kidney stones, or are getting kidney dialysis; have a history of
metabolic acidosis (too much acid in the blood); have liver problems; have weak, brittle or softbones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or
breathing problems; have eye problems, especially glaucoma; have diarrhea; have a growth
problem; are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet; arehaving surgery; are pregnant or planning to become pregnant; or if you are breastfeeding. The
medicine in Qudexy XR (topiramate) passes into your breast milk. It is not known if the
medicine, topiramate, that passes into breast milk can harm your baby. Talk with yourhealthcare provider about the best way to feed your baby if you take Qudexy XR.
Tell your healthcare provider about all the medicines you take, including prescription andover-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare
provider if you take metformin (e.g., Glucophage); valproic acid (e.g., Depakene or Depakote);
any medicines that impair or decrease your thinking, concentration, or muscle coordination; birthcontrol pills (Qudexy XR may make birth control pills less effective); medicines used to prevent
seizures; or any other carbonic anhydrase inhibitors (e.g., zonisamide or acetazolamide).

Do not stop Qudexy XR without first talking to a healthcare provider. If you have epilepsy
and you stop taking Qudexy XR suddenly, you may have seizures that do not stop. Your
healthcare provider will tell you how to stop taking Qudexy XR slowly.
Do not drink alcohol while taking Qudexy XR. Qudexy XR and alcohol can cause side effects
such as sleepiness and dizziness.
Do not drive a car, swim, climb, or operate heavy machinery until you know how Qudexy
XR affects you. Qudexy XR can slow your thinking and motor skills, and may affect vision.
Even when taking Qudexy XR, some patients with epilepsy will continue to have unpredictableseizures.
This is the most important information to know about Qudexy XR but is notcomprehensive. For more information, talk to your healthcare provider and read the
Medication Guide for Qudexy XR. You can also visit www.upsher-smith.com or call 1-888650-3789.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch or call 1-800-FDA-1088.
About Intravail®
Intravail® is a registered trademark of Neurelis, Inc. Intravail® permeation enhancement
technology enables the non-invasive delivery of a broad range of protein, peptide and nonpeptide drugs (up to 30,000 daltons in size) that can currently only be administered by injection.
Intravail® can be utilized via the oral, buccal, dermal, and intranasal routes of drug
administration.
About Upsher-Smith
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives
to improve the health and lives of patients through an unwavering commitment to high-quality
products and sustainable growth. Since 1919, it has brought generics and brands to a widearray of customers backed by an attentive level of service, strong industry relationships, anddedication to uninterrupted supply.
As Upsher-Smith celebrates its 100-year anniversary, the company enters a newambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co.,
Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on
an exciting new chapter as they seek to deliver the best value for their stakeholders, and mostimportantly, Do More Good™ for the patients they serve. For more information, visit
www.upsher-smith.com.
Qudexy, Zembrace, SymTouch, Tosymra, Access Pathways, Platinum Pass and Do More Good aretrademarks of Upsher-Smith Laboratories, LLC.

Intravail is a registered trademark of Neurelis, Inc.
Imitrex is a registered trademark of Glaxo Group Limited.
*Restrictions apply. Maximum of eight single-dose nasal spray units per month. Medicare, Medicaid, andother federal and state health care program patients are not eligible.
**Data derived from a pharmacokinetic pilot study of 18 healthy subjects.

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Reference
1. Bigal M, Rapoport A, Aurora S, Sheftell F, Tepper S, Dahlof C., Satisfaction with Current Migraine
Therapy: Experience From 2 Centers in US and Sweden. Headache. 2007 Apr;47(4):475-9.
https://doi.org/10.1111/j.1526-4610.2007.00752.x
PM-000505.01