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About ONZETRA

Rapid relief is possible with Breath Powered® ONZETRA Xsail

  • PAIN RELIEF in as little as 30 minutes*
  • PAIN FREEDOM for up 2 Days†

*42% of patients achieved significant pain relief vs 27% on placebo.

†At 24 hours, 28% of patients maintained pain freedom vs 12% in the placebo group, and 20% vs 9% were pain-free at 48 hours.

Clinical Trial Information for ONZETRA

TARGET Clinical Trial

Who Participated

230 adults, diagnosed at least 1 year prior to screening with episodic migraine with or without aura, who were randomly assigned to either receive ONZETRA or a placebo.

Study Objectives

  • Studied the efficacy and safety of ONZETRA 22 mg vs placebo
  • Measured the percentage of patients with headache relief at 2 hours
  • Measured the percentage of patients with pain relief and pain freedom at time intervals up to 120 minutes, meaningful relief, rescue medication use, and sustained pain relief at 24 and 48 hours

Results

  • At 30 minutes, 42% of patients achieved significant paint relief vs 27% on placebo
  • At 2 hours, 68% of patients achieved significant pain relief vs 45% on placebo
  • At 48 hours, 34% of patients achieved significant pain relief vs 20% on placebo

The Safety of ONZETRA Xsail

Learn about the common side effects and risks for ONZETRA

  • A mild metallic taste (no patient stopped taking ONZETRA due to abnormal taste)
  • Nasal discomfort
  • Runny or stuffy nose
  • Triptan sensations, which affected 2% or fewer people taking ONZETRA Xsail
Triptan sensations are usually not caused by a heart condition. They include: paraesthesias (tingling or numbness of the skin), flushing, neck pain, and mild transient chest pressure. None of these events were serious or led people to discontinue ONZETRA. However, if you have heart problems or a history of heart problems, be sure to tell your doctor before using ONZETRA. ONZETRA may cause serious side effects and should not be used by certain patients, including those with a history of heart problems or who have had a stroke. These are not all the risks of use for ONZETRA. Tell your doctor about any side effect that bothers you or does not go away. Please see additional Important Safety Information about ONZETRA Xsail below, and the full Prescribing Information, including Patient Information and Instructions for Use.

Do You Have Questions?

Find answers to questions you may have about ONZETRA.
Visit FAQs
Visit FAQs

Get Started with a Doctor

Ready to take control of your acute migraine pain? Make an appointment with a doctor online to learn if prescription ONZETRA is right for you. 

Talk to a Doctor Online about ONZETRA

Get Started with a Doctor

Ready to take control of your acute migraine pain? Make an appointment with a doctor online to learn if prescription ONZETRA is right for you. 

Talk to a Doctor Online about ONZETRA
IMPORTANT SAFETY INFORMATION
What is ONZETRA® Xsail®
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IMPORTANT SAFETY INFORMATION
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ONZETRA Xsail may cause serious side effects, including:

  • Heart attack and other heart problems, which may lead to death. Stop using ONZETRA Xsail and get emergency medical help right away if you have any symptoms of a heart attack like shortness of breath or tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away
  • 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)
  • Serious allergic reactions (symptoms include hives; tongue, mouth, lip, or throat swelling; problems breathing)
  • Medication overuse headaches. Some people who use ONZETRA Xsail too many times may have worse headaches. If your headaches get worse your doctor may decide to stop your treatment with ONZETRA Xsail
  • Serotonin syndrome, a rare but serious problem that can happen in people using ONZETRA Xsail, especially if ONZETRA Xsail is used with antidepressant medicines called SSRIs, SNRIs, or TCAs. Call your doctor right away if you have any of the following symptoms of serotonin syndrome: 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; trouble walking; or nausea, vomiting, or diarrhea
  • Seizures. Seizures have happened in people taking sumatriptan who have never had seizures before

The most common side effects of ONZETRA Xsail are abnormal taste, discomfort of your nose or throat, runny nose, and stuffy nose. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

Who should not take ONZETRA Xsail?

Do not take ONZETRA Xsail or stop using ONZETRA Xsail if you:

  • Have heart problems or a history of heart problems
  • Have had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
  • Have uncontrolled high blood pressure
  • Have hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your doctor
  • Have peripheral vascular disease (narrowing of blood vessels to the legs, arms, stomach, intestines, or kidneys)
  • Have taken other migraine medications in the last 24 hours, including other triptans, ergots, or ergot-type medications. Ask your doctor for a list of these medicines if you are not sure
  • Are taking a medicine called a monoamine oxidase inhibitor (MAOI). MAOIs cannot be taken within 14 days before or after taking ONZETRA Xsail
  • Have severe liver problems
  • Have an allergy to sumatriptan, the medicine in ONZETRA Xsail, or any of the components in ONZETRA Xsail

What should I tell my healthcare provider before taking ONZETRA Xsail?

Before you take ONZETRA Xsail, tell your doctor about all your medical conditions and all the medicines you take, including prescription medicines, especially antidepressants, and all over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking ONZETRA Xsail?

ONZETRA Xsail 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.

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.

Please see the full Prescribing Information, including Patient Information and Instructions for Use for ONZETRA Xsail.
What is ONZETRA® Xsail®
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What is ONZETRA® Xsail®
ONZETRA® Xsail® is a prescription medication approved for the acute treatment of migraine, with or without aura in adults. ONZETRA Xsail is used for people who have been told by a healthcare provider that they have migraine headaches. ONZETRA Xsail is not for the prevention of migraines or for other types of headaches, including cluster headache.

© 2022 Currax Pharmaceuticals LLC.
ONZ-0035-001 06/22

All rights reserved. ONZETRA and Xsail are registered trademarks of Currax Pharmaceuticals LLC. Breath Powered is a registered trademark of OptiNose AS.

© 2022 Currax Pharmaceuticals LLC. All rights reserved. ONZETRA and Xsail are registered trademarks of Currax Pharmaceuticals LLC. Breath Powered is a registered trademark of OptiNose AS.
ONZ-0035-001 06/22

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