When Timing Is Everything

Whether it’s waking up with a migraine or experiencing rapid-onset pain, patients want relief—fast.1,2

Fast1

Patients may begin to feel migraine pain relief in as little as 10 minutes (17% of patients vs. 5% for placebo).*

Powerful1

~50% of patients experienced migraine pain relief 30 minutes after administration (47% vs. 15% for placebo).*

Simple

A convenient, ready-to-use auto-injector with:

  • A concealed 29 G needle1
  • A discreet, compact design3
  • No refrigeration needed†

60% of patients experienced migraine pain relief 2 hours after administration (vs. 21% for placebo).1 Results from a single-attack, parallel group design study, where six different doses of sumatriptan injection, including 3 mg, were compared (n=30 in each group) with placebo (n=62).

*Time to onset and degree of pain relief varies by patient.  †Store between 68°F and 77°F. Excursions permitted between 59°F and 86°F.

Zembrace® SymTouch® Offers the Lowest Dose in a Sumatriptan Auto-injector1

Minutes Matter

Proportion of patients with migraine pain relief by time with a 3 mg dose of sumatriptan injection (n=30).1 ‡

‡Results from a single-attack, parallel group design study, where six different doses of sumatriptan injection, including 3 mg, were compared (n=30 in each group) with placebo (n=62).
Use only if a clear diagnosis of migraine has been established. If a patient has no response to the first migraine treated, reconsider the diagnosis before Zembrace SymTouch is administered to treat subsequent attacks. Zembrace SymTouch is not indicated for the prevention of migraine attacks, and is contraindicated in patients with a history of hemiplegic or basilar migraines.

Clinical Evidence – RESTOR Study

Clinical support for the use of Zembrace SymTouch was provided by the RESTOR study and the open-label extension thereof.4,5 The RESTOR study was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated the effectiveness and safety of Zembrace SymTouch for acute migraine treatment.4 A total of 268 participants with episodic migraine were randomized to receive either Zembrace SymTouch or a placebo for a single moderate-to-severe migraine attack.4

Results demonstrated that 51.0% of participants in the Zembrace SymTouch group achieved pain freedom at 2 hours compared to 30.8% in the placebo group (P = 0.0023). Zembrace SymTouch also showed significant superiority over placebo at earlier timepoints (as brief as 30 minutes) for pain freedom, pain relief, and MBS freedom.4

The RESTOR study concluded that Zembrace SymTouch is an effective and well-tolerated option for acute migraine management.4 Treatment-emergent adverse events (TEAEs) were reported by 33.3% of participants receiving Zembrace SymTouch compared to 13.4% in the placebo group, with the most common being injection site swelling (7.2%) and pain (7.2%). Importantly, triptan-related sensations such as chest discomfort were minimal in the Zembrace SymTouch group (0.9%).4

Clinical Evidence – RESTOR Open-Label Extension Study

The subsequent 8-week open-label extension study evaluated the efficacy, tolerability, and safety of Zembrace SymTouch in treating multiple migraine attacks.5 The study included 234 subjects with episodic migraine who treated a total of 848 migraine episodes with 1042 doses of Zembrace SymTouch.5 At 2 hours post-dose across four attacks, pain freedom rates ranged from 57.6% to 66.3%, and pain relief rates were between 81.7% and 88.4%.5 Freedom from the MBS, nausea, photophobia, and phonophobia also showed consistent efficacy across attacks. TEAEs were reported by 40.6% of subjects, with injection site reactions being the most common. Most TEAEs were mild, and only 2.1% of subjects discontinued due to adverse events.5 The study concluded that Zembrace SymTouch was effective, tolerable, and safe for acute treatment of multiple migraine attacks over 8 weeks, with consistent responses on pain and associated symptoms.

Together these findings suggest that the 3 mg dose of subcutaneous sumatriptan in Zembrace SymTouch offers a safe and effective alternative to higher doses for managing migraines.

Enhanced Tolerability with Zembrace SymTouch

More than 90% of patients reported no triptan-related adverse events (AEs)

A low incidence of triptan-related AE has been observed in clinical trials4,5

  • 2% of patients treated with Zembrace SymTouch reported ≥1 triptan-related AE versus 2.5% of patients who received placebo4
  • No triptan-related AE exceeded an incidence of 3%4
  • The incidence of triptan-related AEs decreased over multiple treated migraine attacks5

Multicenter, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of Zembrace SymTouch compared with placebo in adults with episodic migraine with or without aura (N=230),4 followed by an 8-week open-label extension.5

Convenient To Carry and Easy-To-Use

Simple, two-step injection process with the smallest needle in a sumatriptan pen (auto-injector)1

Zembrace SymTouch Is RANKED FIRST6

Zembrace SymTouch was ranked first in performance and preference compared with other subcutaneous sumatriptan autoinjectors for all subjective factors, including:

✔  overall ease-of-use

✔  intuitiveness

✔  convenience

 ✔  portability

 ✔  control

 ✔  least intimidating

References:
1) Zembrace SymTouch [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) Brand-Schieber E, et al. Med Devices (Auckl). 2016;9:131137.
4) Landy S, et al. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: a multicenter, randomized, double-blind, placebo-controlled study. J Headache Pain. 2018 Aug 15;19(1):69.
5) Landy S, et al. Efficacy and safety of DFN-11 (sumatriptan injection, 3 mg) in adults with episodic migraine: an 8-week open-label extension study. J Headache Pain. 2018 Aug 15;19(1):70.
6) Andre AD, et al. Subcutaneous sumatriptan delivery devices: comparative ease of use and preference among migraineurs. Patient Prefer Adherence. 2017 Jan 19;11:121-129.
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Do not take Zembrace® SymTouch® if you have hemiplegic migraines or basilar migraines or to treat cluster headache.

IMPORTANT SAFETY INFORMATION
Zembrace SymTouch (Zembrace) 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

Zembrace 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 Zembrace 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.

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

Zembrace 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 Zembrace include: pain and redness at 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.

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 Zembrace. For more information, ask your provider.

This is the most important information to know about Zembrace 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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