Rethinking Acute Migraine Treatment

Migraine is the third‑highest neurological cause of time lost to ill health and disability worldwide1

Oral migraine treatments aren't always predictable, especially when:

Migraine symptoms include GI disruption that can impair absorption2-4

Patients need fast onset of action during rapidly escalating attacks5

Patients are taking GI‑impacting therapies (e.g., GLP-1s)6

Many common medications, like GLP‑1s, can cause gastroparesis or delayed gastric emptying7

Natalie

36-year-old,
Female

Not an actual patient. For illustrative purposes only.

Migraine treatment affected by concomitant medications

  • Diagnosed with migraine without aura 6 years ago
  • Averages 4–5 migraine attacks per month

Current Presentation

  • Uses a combination of an OTC NSAID and a triptan for acute migraines
  • Noticed medications were not providing relief as rapidly as they used to after starting on a GLP‑1
  • Attacks are debilitating and often occur early in the morning

Why consider Zembrace® SymTouch® or Tosymra®?

See how non‑oral options like ZEMBRACE SYMTOUCH and TOSYMRA bypass immediate hepatic metabolism

~40% of patients experience morning migraine and may benefit from a rapid, non‑oral therapy5,8,9

Struggles with migraine in the morning

  • Diagnosed with migraine with aura 2 years ago
  • College student; reports high levels of school-related stress

Current Presentation

  • Averages 5–6 migraine attacks per month
  • Frequently wakes up with a fully developed migraine already at moderate-to-severe intensity
  • Morning attacks often occur on school days after staying up late studying

Why consider ZEMBRACE SYMTOUCH or TOSYMRA?

See relief data for ZEMBRACE SYMTOUCH and TOSYMRA

Tyler

22-year-old,
Male

Not an actual patient. For illustrative purposes only.

References: 1. Migraine and other headache disorders. World Health Organization. October 24, 2025. Accessed March 24, 2026. https://www.who.int/news-room/fact-sheets/detail/headache-disorders. 2. Newman LC. Why Triptan Treatment Can Fail: Focus on Gastrointestinal Manifestations of Migraine. Headache J Head Face Pain. 2013;53(S1):11-16. doi:10.1111/head.12111 3. Ailani J, Burch RC, Robbins MS, the Board of Directors of the American Headache Society. The American Headache Society Consensus Statement: Update on integrating new migraine treatments into clinical practice. Headache J Head Face Pain. 2021;61(7):1021-1039. doi:10.1111/head.14153 4. Diener HC, Tassorelli C, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019;39(6):687-710. doi:10.1177/0333102419828967 5. Puledda F, Sacco S, Diener HC, et al. International Headache Society global practice recommendations for the acute pharmacological treatment of migraine. Cephalalgia. 2024;44(8):03331024241252666. doi:10.1177/03331024241252666 6. Hooper L, Liu S, Pai MP. GLP‐1RA‐induced delays in gastrointestinal motility: Predicted effects on coadministered drug absorption by PBPK analysis. Pharmacother J Hum Pharmacol Drug Ther. 2025;45(4):211-219. doi:10.1002/phar.70007 7. Mekaroonkamol P, Tiankanon K, Rerknimitr R. A New Paradigm Shift in Gastroparesis Management. Gut Liver. 2022;16(6):825-839. doi:10.5009/gnl210309 8. van Oosterhout W, van Someren E, Schoonman G, et al. Chronotypes and circadian timing in migraine. Cephalalgia. 2018;38(4):617-625. doi:10.1177/0333102417698953 9. Dodick DW. Migraine. Lancet. 2018;391(10127):1315-1330. doi:10.1016/S0140-6736(18)30478-1

INDICATION/LIMITATIONS OF USE

ZEMBRACE® SymTouch® (sumatriptan succinate) injection and TOSYMRA® (sumatriptan) nasal spray are indicated for the acute treatment of migraine with or without aura in adults. ZEMBRACE SymTouch or TOSYMRA should only be used where a clear diagnosis of migraine has been established. ZEMBRACE SymTouch and TOSYMRA are not indicated for the prevention of migraine attacks or for the treatment of cluster headache.

IMPORTANT SAFETY INFORMATION

ZEMBRACE SymTouch and TOSYMRA are 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, transient ischemic attack (TIA), or hemiplegic or basilar migraine
  • Peripheral vascular disease
  • Ischemic bowel disease
  • Uncontrolled hypertension
  • Recent (ie, within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-hydroxytryptamine1 (5-HT1) agonist
  • Concurrent or recent (within 2 weeks) use of a monoamine oxidase-A (MAO-A) inhibitor
  • Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen)
  • Severe hepatic impairment

WARNINGS AND PRECAUTIONS

  • Myocardial ischemia/infarction, Prinzmetal's angina: These events may occur even in patients without known cardiovascular disease. Perform cardiac evaluation in triptan-naive patients with multiple risk factors and, if satisfactory, administer the first dose of ZEMBRACE SymTouch or TOSYMRA in a medically supervised setting
  • Arrhythmias: Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue ZEMBRACE SymTouch or TOSYMRA if these disturbances occur
  • Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Commonly occur after treatment with 5-HT1 agonists and are usually noncardiac in origin. Perform a cardiac evaluation in patients with cardiac risk
  • Cerebrovascular events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. Discontinue ZEMBRACE SymTouch or TOSYMRA if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed with migraine or in patients who present with atypical symptoms, exclude other potentially serious neurological conditions
  • Other vasospasm reactions: 5-HT1 agonists, including ZEMBRACE SymTouch and TOSYMRA, may cause noncoronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before using ZEMBRACE SymTouch or TOSYMRA
  • Medication overuse headache: Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs and treatment of withdrawal symptoms, may be necessary
  • Serotonin syndrome: May occur with triptans, including ZEMBRACE SymTouch and TOSYMRA, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors. The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. Discontinue ZEMBRACE SymTouch or TOSYMRA if serotonin syndrome is suspected
  • Increase in blood pressure: Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with ZEMBRACE SymTouch or TOSYMRA
  • Hypersensitivity reactions: Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. ZEMBRACE SymTouch and TOSYMRA are contraindicated in patients with a history of hypersensitivity reaction to sumatriptan
  • Seizures: Seizures have been reported following administration of sumatriptan, with or without predisposing factors. ZEMBRACE SymTouch or TOSYMRA should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold
  • Local irritation: For TOSYMRA nasal spray only, local irritative symptoms were reported in approximately 46% of patients with TOSYMRA in an open-label trial that allowed repeated use of TOSYMRA over the course of 6 months. The most common local irritative symptoms were application site reaction (eg, burning sensations in the nose), dysgeusia, and throat irritation. Approximately 0.5% of the cases were reported as severe

ADVERSE REACTIONS

The most common adverse reactions (≥5% and >placebo) were injection site reactions (for ZEMBRACE SymTouch only), tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness/paresthesia.

For TOSYMRA nasal spray only, in an open-label study allowing repeated use of TOSYMRA over 6 months, 46% of patients reported local irritative symptoms, the most common of which were application site reaction, dysgeusia, and throat irritation.

DRUG INTERACTIONS

  • Ergot-containing drugs: Reported to cause prolonged vasoplastic reactions
  • MAO-A inhibitors: Increase systemic exposure by 2-fold
  • Other 5-HT1 agonists: Vasoplastic effects may be additive
  • SSRIs, SNRIs, TCAs, and MAO inhibitors: Serotonin syndrome has been reported

USE IN SPECIFIC POPULATIONS

Pregnancy: Disease-Associated Maternal and/or Embryo/Fetal Risk: Several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.

Lactation: Sumatriptan is excreted in human milk following subcutaneous administration. There are no data on the effects of sumatriptan on a breastfed infant or the effects on milk production. Infant exposure can be minimized by avoiding breastfeeding for 12 hours after treatment with ZEMBRACE SymTouch or TOSYMRA.

Pediatric use: The safety and effectiveness in pediatric patients have not been established. ZEMBRACE SymTouch or TOSYMRA is not recommended for use in patients younger than 18 years of age.

Geriatric patients: Clinical trials of sumatriptan did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. Dose selection for an elderly patient should usually start at the low end of the dosing range. A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (eg, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving ZEMBRACE SymTouch or TOSYMRA.

Please see additional safety information in the full Prescribing Information for ZEMBRACE SymTouch and TOSYMRA.

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1‑888‑869‑7633, or the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

MLT‑HCP‑260015 05/26

MLT‑HCP‑260011 05/26