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FDA Approves Onzetra Xsail Migraine Medication

February 1, 2016
Administered intranasally, low-dose sumatriptan is fast-acting for the acute treatment of migraines.

The US Food and Drug Administration (FDA) announced the approval of Onzetra Xsail (fast-acting sumatriptan nasal powder) for the acute treatment of migraine in adult patients with or without aura, according to Avanir Pharmaceuticals. 

The product consists of a low dose (22 mg) of sumatriptan powder "that is delivered using the Xsail Breath Powered Delivery Device," noted the company. 

“While there are many acute migraine treatment options available, more than 70% of patients are not fully satisfied with their current migraine treatment. Given this high dissatisfaction, there remains an unmet need to provide patients with fast-acting, well tolerated therapies that deliver consistent relief,” said Stewart Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth, in a press release from Avanir.

How It Works

The Xsail delivery system is activated by a user's breath to propel medication deep into the nasal cavity, and area rich with blood vessles where absorption is more efficient and consistent. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity—which prevents patients from swallowing any medication.

"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," said Roger K. Cady, MD, co-founder and director, Headache Care Center, Springfield, Missouri, and associate executive chairman, National Headache Foundation.

Clinical Trials

The FDA based their approval on clinical trials, including the TARGET trial. In that trial, 230 migraine patients were randomly assigned to two treatment arms:  Onzetra or placeb. The patients were taught how to self-administer the nasal powder using the Xsail 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 4 point scale with headache relief defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) or complete relief (grade 0). "Study results demonstrated that a significantly greater proportion of Onzetra Xsail patients reported headache relief at 30 minutes compared with controls (41.7% vs. 26.9%, P=0.03); and at every time point up to 2 hours post-dose (67.6% vs. 45.2%, P=0.002). 

The treatment was well tolerated with a low incidence of adverse events (AEs). The most common AEs included abnormal product taste (20%), nasal discomfort (11%), rhinorrhea (5%) and rhinitis (2%); local AEs were transient and almost exclusively mild to moderate in severity, noted the company.

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 (ie, 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
  • Other serious adverse events associated with the use of sumatriptan or 5-HT1 agonists include: myocardial ischemia/infarction, Prinzmetal's angina, arrhythmias; chest, throat, neck and/or jaw pain/tightness/pressure; cerebral hemorrhage, subarachnoid hemorrhage, and stroke; peripheral vascular ischemia, gastrointestinal vascular ischemia/infarction, and Raynaud’s syndrome, medication overuse headache; serotonin syndrome; significant elevation in blood pressure; anaphylactic/anaphylactoid reactions; and seizures.

For more information, please visit the Onzetra Web site

Last updated on: February 1, 2016