About Tosymra®

Whether it’s waking up with a migraine or experiencing rapid-onset pain, patients want relief—fast.1-3

Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo)*1-3

Efficacy of Tosymra is based on relative bioavailability to subcutaneous sumatriptan at a dose of 4 mg. In a clinical study, this dose of sumatriptan resulted in 57% of patients achieving pain relief at 2 hours vs. 21% for placebo.1

 

*Time to onset and degree of pain relief varies by patient.

Ensure your patients are prepared

Oral therapy may not be the optimal treatment for every migraine. See why Tosymra uses the novel ingredient Intravail®.

Tosymra delivers migraine pain relief in as little as 10 minutes with just one spray for some patients (13% vs. 5% for placebo).*1-3

Efficacy of Tosymra is based on relative bioavailability to subcutaneous sumatriptan at a dose of 4 mg. In a clinical study, this dose of sumatriptan resulted in 57% of patients achieving pain relief at 2 hours vs. 21% for placebo.1
*Time to onset and degree of pain relief varies by patient.

Ensure your patients are prepared

Oral therapy may not be the optimal treatment for every migraine. See why Tosymra uses the novel ingredient Intravail®.

Tosymra achieved peak plasma concentration 8× faster than Imitrex® nasal spray4

Mean sumatriptan plasma concentration-time profile

  • Tosymra attained 3× the peak plasma concentration (Cmax) compared with Imitrex4
  • These results were obtained from a randomized, three-way crossover study comparing Tosymra with commercially available intranasal sumatriptan 20 mg (Imitrex) in 18 healthy, fasted adults

Tosymra achieved peak plasma concentration faster than 4 mg subcutaneous sumatriptan4

Mean sumatriptan plasma concentration-time profile

  • Time to mean peak plasma concentration (tmax) of sumatriptan was observed 10 minutes after a dose of Tosymra, 5 minutes earlier than the subcutaneous sumatriptan dose (P <.0001)4
  • These results were obtained from a open-label, randomized, single-dose, three-way crossover bioavailability study comparing Tosymra with subcutaneous sumatriptan injection in 73 or 75 patients4

Tosymra Long-Term Safety and Tolerability Study

A 6-month, open-label, repeat-dose safety study assessed the safety and tolerability of Tosymra in 167 adult patients.5 Tosymra was well-tolerated, with a low rate of treatment-emergent adverse events (TEAEs). Over the 6-month study, 3292 doses of Tosymra were used to treat 2211 migraine attacks.5

*Percent of patients experiencing the event at least once during the course of the study. †Included nasal or nostril burning or stinging. ‡Only 1 event of sinusitis was considered possibly related to Tosymra.
  • Five (3%) patients discontinued due to adverse events.5
  • Overall, 2.9% of doses were associated with a triptan-related TEAE.5
  • Three-quarters of triptan-related adverse events were mild; none were severe.5

Intravail® Controlled Permeation Enhancer

Intravail (n-Dodecyl beta-D-maltoside [DDM]) is a non-toxic, odorless, and tasteless permeation enhancer that allows more medication to be absorbed through the nasal mucosa, thereby avoiding the gastrointestinal tract and first pass metabolism.7-9

Intravail®:

  • facilitates paracellular absorption through the nasal mucosa by:
    • transiently relaxing tight junctions between nasal mucosal cells
    • facilitating drug passage into the systemic circulation of molecules up to 30 kDa, whereas the molecular weight of sumatriptan is 0.2954 kDA8
  • enables Tosymra to achieve 87% of the bioavailability relative to that provided by a 4 mg subcutaneous sumatriptan injection1
  • belongs to a class of compounds known as alkylsaccharides7-9
    • Alkylsaccharides are used broadly as food additives and have well characterized safety and metabolic profiles8
    • Alkylsaccharides metabolize quickly and cleanly to natural dietary components, namely, a sugar and a fatty acid8
    • FDA designation of Generally Regarded as Safe (GRAS) for food applications8
  • was non-irritating when tested at >100× the concentration used in Tosymra®7

Intravail® Controlled Permeation Enhancer

Intravail (n-Dodecyl beta-D-maltoside [DDM]) is a non-toxic, odorless, and tasteless permeation enhancer that allows the medication to bypass the GI tract, avoiding first pass metabolism8-10.

Intravail®:

  • facilitates paracellular absorption through the nasal mucosa by:
    • transiently relaxing tight junctions between nasal mucosal cells
    • facilitating drug passage into the systemic circulation of molecules up to 30 kDa, whereas the molecular weight of sumatriptan is 0.2954 kDA8
  • enables Tosymra to achieve 87% of the bioavailability relative to that provided by a 4 mg subcutaneous sumatriptan injection1
  • belongs to a class of compounds known as alkylsaccharides7-9
    • Alkylsaccharides are used broadly as food additives and have well characterized safety and metabolic profiles8
    • Alkylsaccharides metabolize quickly and cleanly to natural dietary components, namely, a sugar and a fatty acid8
    • FDA designation of Generally Regarded as Safe (GRAS) for food applications8
  • was non-irritating when tested at >100× the concentration used in Tosymra®7
References:
1) Tosymra [prescribing information]. Chatham, NJ: Tonix Medicines, Inc.: 2023.
2) Mathew NT, et al.Dose ranging efficacy and safety of subcutaneous sumatriptan in the acute treatment of migraine.US Sumatriptan Research Group.Arch Neurol. 1992;49(12):1271-1276.
3) Wendt J, et al.A randomized, double-blind, placebo-controlled trial of the efficacy and tolerability of a 4-mg dose of subcutaneous sumatriptan for the treatment of acute migraine attacks in adults.Clinical Therapeutics. 2006;28(4):517-526. 
4) Munjal S, et al. 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.
5) Munjal S, et al. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine. J Headache Pain. 2017;18(1):31.
6) Data on file. Tonix Medicines, Inc., Chatham, NJ.
7) Maggio ET. Intravail®: Highly effective intranasal delivery of peptide and protein drugs. Expert Opinion Drug Delivery. 2006;3(4):529-539.
8) Maggio ET, Pillion DJ. High efficiency intranasal drug delivery using Intravail® alkylsaccharide absorption enhancers. Drug Delivery and Translational Research. 2013;3(1):16-25.
9) Ghadiri M, et al. Strategies to enhance drug absorption via nasal and pulmonary routes. Pharmaceutics. 2019;11(3):113.
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Do not take Tosymra® if you have hemiplegic migraines or basilar migraines or to treat cluster headache.

IMPORTANT SAFETY INFORMATION
Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency medical help if you have any signs of heart attack:

  • discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
  • severe 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 or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.

Do not use Tosymra if you have:

  • history of heart problems
  • narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
  • uncontrolled high blood pressure
  • hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
  • had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
  • severe liver problems
  • taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
  • 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 your provider for a list of these medicines if you are not sure.
  • an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.

Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.

Tosymra may cause serious side effects including:

  • changes in color or sensation in your fingers and toes
  • sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
  • increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
  • medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
  • serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures even in people who have never had seizures before

The most common side effects of Tosymra include: tingling dizziness; feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Tosymra. For more information, ask your provider.

This is the most important information to know about Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.

You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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