(BPT) – People who suffer from migraine know that they’re more than just bad headaches.
Migraine is a neurological disorder in which the nerves release inflammatory substances that cause signals to be sent to your brain, resulting in painful throbbing that can be accompanied by nausea, vomiting or sensitivity to light and sound. Migraine is the third most prevalent illness in the world<a href=”#_edn1″ rel=”nofollow” name=”_ednref1″ id=”_ednref1″></a>, and more than 36 million Americans suffer from migraine headaches.<a href=”#_edn2″ rel=”nofollow” name=”_ednref2″ id=”_ednref2″></a>
Melissa H. has suffered migraine attacks for more than 15 years. Frequent migraines have greatly impacted the life of the 35-year-old teacher and mother of a toddler.
“My migraines were affecting every aspect of my life,” Melissa says. “There were times that I wanted to continue my workday or I wanted to spend time with my family, but instead, I had to go lie down in a dark, quiet room to deal with my migraine.”
For migraine sufferers like Melissa, pain relief cannot come fast enough, which often leads many to try a variety of medications.
In January 2017, the U.S. Food and Drug Administration approved ONZETRA® Xsail® (sumatriptan nasal powder), which uses the most prescribed migraine medication — sumatriptan — but takes a different route. ONZETRA Xsail is the first Breath Powered® nasal medication delivery system for the acute treatment of migraine. The device is activated by a user’s breath to propel medication to the back of the nose, an area that is rich with blood vessels, and provides targeted delivery with the potential for fast absorption.
“When it comes to migraine medication, patients often think of pills, but nasal delivery can offer fast pain relief — and that’s something my patients really appreciate,” says Dr. Anne Calhoun, headache specialist in Durham, NC. “The nose is well-suited to the delivery of migraine medication because of an extensive network of blood vessels that can absorb the medication very quickly.”
In clinical trials of ONZETRA, almost half of migraine sufferers experienced pain relief in as early as 30 minutes (42 percent vs 27 percent on placebo) and 68 percent experienced pain relief in 2 hours vs 45 percent on placebo. In addition, more than 90 percent of patients found ONZETRA Xsail easy to use. For more information about ONZETRA Xsail, talk to your doctor or visit <a href=”http://www.ONZETRA.com” target=”_blank” rel=”nofollow”>www.ONZETRA.com</a>.
<strong><span style=”text-decoration: underline”>Important Safety Information</span></strong>
<strong>What is ONZETRA<sup>TM</sup> Xsail<sup>TM</sup> (sumatriptan nasal powder) used for?</strong>
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.
<strong>What important information should I know about ONZETRA Xsail?</strong>
ONZETRA Xsail may cause serious side effects, including:
<ul><li><strong>Heart attack and other heart problems</strong>, 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 <strong>shortness of breath or tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw that is severe or does not go away</strong></li><li><strong>Changes in color or sensation in your fingers and toes</strong> <strong>(Raynaud’s syndrome)</strong></li><li><strong>Stomach and intestinal problems</strong> <strong>(gastrointestinal and colonic ischemic events)</strong></li><li><strong>Problems with blood circulation to your legs and feet</strong> <strong>(peripheral vascular ischemia)</strong></li><li><strong>Serious allergic reactions</strong> <strong>(symptoms include hives; tongue, mouth, lip, or throat swelling; problems breathing)</strong></li><li><strong>Medication overuse headaches</strong>. 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</li><li><strong>Serotonin syndrome</strong>, 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</li><li><strong>Seizures</strong>. Seizures have happened in people taking sumatriptan who have never had seizures before</li></ul>
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.
<strong>Who should not take ONZETRA Xsail?</strong>
Do not take ONZETRA Xsail or stop using ONZETRA Xsail if you:
<ul><li>Have heart problems or a history of heart problems</li><li>Have had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation</li><li>Have uncontrolled high blood pressure</li><li>Have hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your doctor</li><li>Have peripheral vascular disease (narrowing of blood vessels to the legs, arms, stomach, intestines, or kidneys)</li><li>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</li><li>Are taking a medicine called a monoamine oxidase inhibitor (MAOI). MAOIs cannot be taken within 14 days before or after taking ONZETRA Xsail</li><li>Have severe liver problems</li><li>Have an allergy to sumatriptan, the medicine in ONZETRA Xsail, or any of the components in ONZETRA Xsail</li></ul>
<strong>What should I tell my healthcare provider before taking ONZETRA Xsail?</strong>
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.
<strong>What should I avoid while taking ONZETRA Xsail?</strong>
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 <a href=”file:///C:/Users/Lisa/Documents/Lehman%20Freelance/www.fda.gov/medwatch” target=”_blank” rel=”nofollow”>www.fda.gov/medwatch</a> or call 800-FDA-1088.
<strong>For additional Important Safety Information about ONZETRA Xsail</strong><strong>, please see the</strong> <a href=”https://www.onzetra.com/sites/default/files/onzetra_xsail_prescribing_information.pdf” rel=”nofollow”><strong>full Prescribing Information</strong></a><strong>, including Patient Information, and</strong> <a href=”https://www.onzetra.com/sites/default/files/onzetra_xsail_IFU.pdf” target=”_blank” rel=”nofollow”><strong>Instructions for Use</strong></a><strong>.</strong>
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<a href=”#_ednref1″ rel=”nofollow” name=”_edn1″ id=”_edn1″></a> Migraine Research Foundation. Migraine Facts. <a href=”https://migraineresearchfoundation.org/about-migraine/migraine-facts/” rel=”nofollow”>https://migraineresearchfoundation.org/about-migraine/migraine-facts/</a>. Accessed August 18, 2016.
<a href=”#_ednref2″ rel=”nofollow” name=”_edn2″ id=”_edn2″></a> Migraine.com. Migraine Statistics. <a href=”https://migraine.com/migraine-statistics/” rel=”nofollow”>https://migraine.com/migraine-statistics/</a>. Accessed August 18, 2016.
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