Migraine patients will soon have a new actute treatment available in yet another new delivery system. ONZETRA Xsail™, developed by Avanir Pharmaceuticals, was approved by the FDA on January 28. The FDA approved it for the acute treatment of migraine with aura and migraine without aura in adults.
The approval of ONZETRA Xsail is based on data from phase II and phase III trials, safety data from more than 300 patients, and reference data from the extensive clinical use of sumatriptan over the past 20 years. In the pivotal TARGET trial, 230 migraine sufferers were randomized to self-administer either ONZETRA or placebo using the Xsail Breath Powered Delivery Device when they had moderate to severe migraine pain. Pain scores were then assessed at various time points after administration. Pain was evaluated using a four-point scale with headache relief defined as a reduction from moderate or severe pain to mild or complete relief. Study results demonstrated that a significantly greater proportion of ONZETRA Xsail patients reported relief at 30 minutes (41.7 percent in the ONZETRA group vs. 26.9 percent in the placebo group) and at every time point up to two hours post-dose compared with those using the placebo device (67.6 percent in the ONZETRA group vs. 45.2 percent in the placebo group). ONZETRA was well tolerated with a low incidence of side effects. In addition, in pooled studies, ONZETRA was well tolerated with a low incidence of side effects, with the most common side effects being abnormal product taste (20 percent), nasal discomfort (11 percent), rhinorrhea (5 percent) and rhinitis (2 percent).
ONZETRA Xsail delivers powdered sumatriptan (Imitrex). The breath powered delivery technology is activated by a user’s breath to propel medication deep into the nasal cavity where absorption is more efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are gently expanded and medication is dispersed deep into the nasal cavity reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduce gastrointestinal absorption.
Dr. Roger K. Cady, M.D., director of the Headache Care Center and associate executive chairman of the National Headache Foundation, commented:
“ONZETRA Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people. The Xsail Breath Powered Delivery Device allows the medication to be deposited deep into the nose, an area that is rich with blood vessels. By delivering the medication here, ONZETRA Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat.”
Since the soft palate seals the nasal cavity, there’s little opportunity for ONZETRA Xsail to go down the throat, as Dr. Cady noted. For those who have tried nasal sprays for migraine and have found the taste and nausea to be problematic, ONZETRA Xsail may offer a viable alternative.
As is the case with other forms of sumatriptan, ONZETRA Xsail is contraindicated for certain patients, including those with a history of coronary artery disease (CAD) or coronary vasospasm. ONZETRA is contraindicated in patients with:
- Ischemic coronary artery disease (CAD) or coronary artery vasospasm, including Prinzmetal’s angina; or Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders
- History of stroke, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; or uncontrolled hypertension
- Recent (i.e., within 24 hours) use of ergotamine-containing or ergot-type medication, or another 5-HT1 agonist; or concurrent or recent (within 2 weeks) use of a MAO-A inhibitor
- Known hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) or severe hepatic impairment
FDA approval doesn’t mean that ONZETRA Xsail will be available immediately. Production of medications can’t start until they’re approved by the FDA, so ONZETRA Xsail will be available once productions has started and the supply is ready to start shipping.
Although sumatriptan isn’t new (Imitrex was first approved in 1992), this delivery system is. Since it doesn’t pass through the gastrointestinal tract, it’s efficacy isn’t impacted by nausea and vomiting. This makes it a valuable new tool in the arsenal of migraine patients.
Press Release. “Avanir Pharmaceuticals Announces FDA Approval of ONZETRA™ Xsail™ (AVP-825) for the Acute Treatment of Migraine in Adults.” Avanir Pharmaceuticals. Aliso Viejo, California. January 28, 2016.
_Reviewed by David Watson, MD. _
Teri Robert is a leading patient educator and advocate and the author of Living Well with Migraine Disease and Headaches. A co-founder of the Alliance for Headache Disorders Advocacy and the American Headache and Migraine Association, she received the National Headache Foundation’s Patient Partners Award and a Distinguished Service Award from the American Headache Society. Teri can be found on her website, and blog, Facebook, Twitter, StumbleUpon, Pinterest, LinkedIn, and Google+.