TOSYMRA achieves median peak plasma concentration faster than injectable Imitrex® (sumatriptan)1

  • TOSYMRA is a novel nasal spray formulation of sumatriptan 10 mg developed with Intravail® technology1,2
    • TOSYMRA with Intravail® technology, n-Dodecyl beta-D-maltoside or DDM, allows efficient transmucosal absorption of sumatriptan1
  • Pharmacokinetic (PK) equivalence to a 4-mg subcutaneous (subQ) injection of Imitrex® (sumatriptan) has been shown1,2*
    • Median peak plasma concentration of sumatriptan was observed 5 minutes faster with TOSYMRA compared with 4-mg and 6-mg subQ injections of Imitrex® (sumatriptan)1
Mean sumatriptan plasma concentration-time profile: TOSYMRA vs subQ Imitrex®
Mean sumatriptan plasma concentration-time profile: TOSYMRA vs subQ Imitrex®

*Following administration of a single dose of TOSYMRA in 73 healthy subjects, the relative bioavailability of sumatriptan was approximately 87% (90% confidence interval [CI]: 82-94) of that obtained following a 4-mg subQ injection of Imitrex® (sumatriptan).2

A 10-mg dose of TOSYMRA demonstrated a markedly increased rate and extent of sumatriptan absorption when compared with Imitrex® (sumatriptan) 20-mg nasal spray1

TOSYMRA achieved peak
plasma concentration

8x faster
median time of 15 minutes vs 120 minutes1

The bioavailability
of TOSYMRA was

2x higher
in the 2 hours following administration1

Mean peak plasma concentration
of TOSYMRA was

3x faster
with half the dose
of sumatriptan1

PK data indicates that minimal to no swallowing of sumatriptan occurred after administration of TOSYMRA1

  • Double peaks were observed for Imitrex® (sumatriptan) 20-mg nasal spray1

Double peaks in plasma serum concentration suggest that only some of the sumatriptan was absorbed nasally after administration, while more of the drug was swallowed and absorbed through the gastrointestinal system at a later time.3

Mean sumatriptan plasma concentration-time profile: TOSYMRA vs Imitrex® (sumatriptan) 20-mg nasal spray
Mean sumatriptan plasma concentration-time profile: TOSYMRA vs Imitrex® (sumatriptan) 20-mg nasal spray

Each patient has a distinct migraine experience

Meet Jenn: has migraine-associated nausea

Age 28
Profession Pharmacist
Background

Jenn experiences migraines 2 to 4 times per month. Her migraines typically start as mild and then progress slowly to moderate-to-severe pain. Though gradual, these migraines can last up to 2 days, and relief is typically slow. Jenn also has a history of gastrointestinal (GI) distress and gastroparesis.

Current/Previous Treatment

Jenn typically treats her migraines with oral triptans, but nausea makes it difficult for her to take her medication.

Chief Complaint

Typically, Jenn’s migraines are accompanied by nausea, requiring the addition of antiemetic medication. It is possible that gastroparesis has delayed the absorption of oral migraine treatment, leaving her with migraines that are often slow to respond to treatment.

Jenn Needs
  • A migraine medication that provides rapid and effective relief
  • An alternative to oral medication when she is nauseated
Meet Jenn: Patient with gastric issues Not an actual patient.

References: 1. Munjal S, Gautam A, Offman E, Brand-Schieber E, Allenby K, Fisher DM. A randomized trial comparing the pharmacokinetics, safety, and tolerability of DFN-02, an intranasal sumatriptan spray containing a permeation enhancer, with intranasal and subcutaneous sumatriptan in healthy adults. Headache. 2016;56(9):1455-1465. 2. TOSYMRA [package insert]. Maple Grove, MN: Upsher-Smith Laboratories, LLC; 2019. 3. Wermeling DPH, Miller JD, Archer SM, Manaligod JM, Rudy AC. Bioavailability and pharmacokinetics of lorazepam after intranasal, intravenous, and intramuscular administration. J Clin Pharmacol. 2001;41:1225-1231. 4. Data on file. Upsher-Smith Laboratories, Maple Grove, MN.

IMPORTANT SAFETY INFORMATION

TOSYMRA™ is contraindicated in patients with:

  • Ischemic Coronary Artery Disease (CAD) or coronary artery vasospasm (including Prinzmetal’s angina)
  • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • History of stroke or transient ischemic attack or history of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication, or another 5-HT1 agonist
  • Concurrent or recent (within 2 weeks) use of a monoamine oxidase (MAO)-A inhibitor
  • Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
  • Severe hepatic impairment

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. TOSYMRA, like other 5-HT1 agonists, may cause coronary artery vasospasm. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving TOSYMRA. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of TOSYMRA in a medically supervised setting and performing an ECG immediately following administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of TOSYMRA.

Life-threatening disturbances of cardiac rhythm, leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue TOSYMRA if any of these cardiovascular disturbances occur.

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue TOSYMRA if these occur.

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.

TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.

Overuse of acute migraine drugs may lead to medication overuse headache. Detoxification of patients and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, and MAO inhibitors. Discontinue TOSYMRA if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with TOSYMRA.

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Most common adverse reactions (≥5% and > placebo) with sumatriptan injection were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

This safety information is not comprehensive. Please refer to the TOSYMRA full Prescribing Information, Patient Information, and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

INDICATION AND USAGE

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

  • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with TOSYMRA, reconsider the diagnosis before TOSYMRA is administered to treat any subsequent attacks.
  • TOSYMRA is not indicated for the preventive treatment of migraine.
  • TOSYMRA is not indicated for the treatment of cluster headache.
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IMPORTANT SAFETY INFORMATION

TOSYMRA™ is contraindicated in patients with:

  • Ischemic Coronary Artery Disease (CAD) or coronary artery vasospasm (including Prinzmetal’s angina)
  • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
  • History of stroke or transient ischemic attack or history of hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (i.e., within 24 hours) use of ergotamine-containing medication, ergot-type medication, or another 5-HT1 agonist
  • Concurrent or recent (within 2 weeks) use of a monoamine oxidase (MAO)-A inhibitor
  • Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
  • Severe hepatic impairment

There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. TOSYMRA, like other 5-HT1 agonists, may cause coronary artery vasospasm. Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors prior to receiving TOSYMRA. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of TOSYMRA in a medically supervised setting and performing an ECG immediately following administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of TOSYMRA.

Life-threatening disturbances of cardiac rhythm, leading to death in some cases, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue TOSYMRA if any of these cardiovascular disturbances occur.

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue TOSYMRA if these occur.

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with sumatriptan injection and are usually non-cardiac in origin.

TOSYMRA may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome.

Overuse of acute migraine drugs may lead to medication overuse headache. Detoxification of patients and treatment of withdrawal symptoms may be necessary.

Serotonin syndrome may occur with TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, and MAO inhibitors. Discontinue TOSYMRA if serotonin syndrome is suspected.

Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with TOSYMRA.

Seizures have been reported following administration of sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Most common adverse reactions (≥5% and > placebo) with sumatriptan injection were tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.

This safety information is not comprehensive. Please refer to the TOSYMRA full Prescribing Information, Patient Information, and Instructions for Use. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

INDICATION AND USAGE

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

  • Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine attack treated with TOSYMRA, reconsider the diagnosis before TOSYMRA is administered to treat any subsequent attacks.
  • TOSYMRA is not indicated for the preventive treatment of migraine.
  • TOSYMRA is not indicated for the treatment of cluster headache.