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TARGET | EFFICACY
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SIGNIFICANT PAIN RELIEF WITHOUT SACRIFICING SUSTAINABILITY6,12

Download a reprint of the pivotal study
Pain Relief Chart

At 30 minutes, 42% of patients achieved significant pain relief

vs 27% on placebo (P<.05)

At 2 hours, 68% of patients achieved significant pain relief

vs 45%, on placebo (P<.05)

At 48 hours, 34% of patients achieved sustained pain relief

vs 20%, on placebo

*P<.05.

Pain Relief Chart

DOWNLOAD A REPRINT OF THE PIVOTAL STUDY

PIVOTAL STUDY OVERVIEW (TARGET)6,12

A phase 3, multicenter, randomized, double-blind, placebo-controlled study. Patients were instructed to treat a moderate-to-severe migraine headache. Additional medications were allowed as rescue therapy beginning 2 hours after the initial treatment.

STUDY ENDPOINTS6
  • Primary endpoint: Percentage of patients with headache relief at 2 hours
  • Select secondary endpoints: 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. Secondary endpoints were prespecified and statistically significant at key time points, but were not adjusted for multiplicity
BASELINE CHARACTERISTICS OF STUDY PATIENTS (N=212)12
  • Mean age: 42 (range 19-64)
  • Average (mean) migraine attacks per month: 4.5 (SD=1.9)
  • Gender and ethnicity: Predominantly female (84%) and Caucasian (86%)
  • Baseline headache severity: 83% moderate, 17% severe

MAJORITY OF PATIENTS ON ONZETRA DID NOT USE A RESCUE MEDICATION IN THE PIVOTAL TRIAL12

63%
63%

of patients who used ONZETRA (n=68) DID NOT USE a rescue medication within 48 hours of the initial dose vs placebo (n=49) (48%)12

 

Patients were instructed to treat a moderate-to-severe migraine headache. Additional medications were allowed as rescue therapy beginning 2 hours after the initial treatment.12

Secondary endpoints were prespecified and statistically significant at key time points, but were not adjusted for multiplicity.

SAFETY AND TOLERABILITY SAFETY AND TOLERABILITY

ADVERSE EVENTS6

Adverse events table

ABNORMAL TASTE WAS GENERALLY DESCRIBED AS MILD.12

In the 2 controlled trials, 20% of patients reported abnormal taste. The majority of patients who reported abnormal taste with ONZETRA described it as mild (77%), while the rest described it as moderate (20%) or severe (3%).6,11

LOW INCIDENCE OF TRIPTAN SENSATIONS12

In clinical trials, triptan sensations were reported in <2% of attacks treated with ONZETRA In clinical trials, triptan sensations were reported in <2% of attacks treated with ONZETRA
  • None of these events were serious or led to study discontinuation6,12
  • These sensations commonly occur after treatment with triptans and are usually noncardiac in origin. However, ONZETRA Xsail is contraindicated in patients with certain cardiac conditions6,12
  • Perform a cardiac evaluation in patients with high cardiac risk6,12

Please click here to see a list of contraindications.

Important Safety Information & Indication

ONZETRA Xsail 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 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

WARNINGS AND PRECAUTIONS

  • Myocardial ischemia/infarction, Prinzmetal's angina: These events may occur even in patients without known cardiovascular disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, consider administering first dose of ONZETRA Xsail in a medically-supervised setting
  • Arrhythmias: Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue ONZETRA Xsail if these disturbances occur
  • Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Commonly occur after treatment with 5-HT1 agonists and are usually non-cardiac in origin. Perform a cardiac evaluation in patients with cardiac risk
  • Cerebrovascular Events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions
  • Other Vasospasm Reactions: 5-HT1 agonists, including ONZETRA Xsail, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before using ONZETRA Xsail
  • Medication Overuse Headache: Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
  • Serotonin Syndrome: May occur with triptans, including ONZETRA Xsail, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. Discontinue ONZETRA Xsail if serotonin syndrome is suspected
  • Increases in Blood Pressure: Increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with ONZETRA Xsail
  • Anaphylactic Reactions: Anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. ONZETRA Xsail is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan
  • Seizures: Seizures have been reported following administration of sumatriptan, with or without predisposing factors. ONZETRA Xsail should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold

Indication/Limitations of Use

ONZETRA® Xsail® (sumatriptan nasal powder) is indicated for the acute treatment of migraine with or without aura in adults. ONZETRA Xsail should only be used where a clear diagnosis of migraine has been established. ONZETRA Xsail is not indicated for the prevention of migraine attacks or for other types of headaches, including cluster headache. 

Important Safety Information

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 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

WARNINGS AND PRECAUTIONS

  • Myocardial ischemia/infarction, Prinzmetal's angina: These events may occur even in patients without known cardiovascular disease. Perform cardiac evaluation in triptan-naïve patients with multiple risk factors and, if satisfactory, consider administering first dose of ONZETRA Xsail in a medically-supervised setting
  • Arrhythmias: Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue ONZETRA Xsail if these disturbances occur
  • Sensations of chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Commonly occur after treatment with 5-HT1 agonists and are usually non-cardiac in origin. Perform a cardiac evaluation in patients with cardiac risk
  • Cerebrovascular Events: Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions
  • Other Vasospasm Reactions: 5-HT1 agonists, including ONZETRA Xsail, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction, splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of a vasospastic reaction following the use of any 5-HT1 agonist, rule out a vasospastic reaction before using ONZETRA Xsail
  • Medication Overuse Headache: Overuse of acute migraine drugs may lead to exacerbation headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms may be necessary
  • Serotonin Syndrome: May occur with triptans, including ONZETRA Xsail, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs). The onset of symptoms usually occurs within minutes to hours of receiving a new or greater dose of a serotonergic medication. Discontinue ONZETRA Xsail if serotonin syndrome is suspected
  • Increases in Blood Pressure: Increases in blood pressure have been reported in patients treated with 5-HT1 agonists. Monitor blood pressure in patients treated with ONZETRA Xsail
  • Anaphylactic Reactions: Anaphylactic reactions have occurred in patients receiving sumatriptan. Such reactions can be life threatening or fatal. ONZETRA Xsail is contraindicated in patients with a history of hypersensitivity reaction to sumatriptan
  • Seizures: Seizures have been reported following administration of sumatriptan, with or without predisposing factors. ONZETRA Xsail should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold

ADVERSE REACTIONS

In clinical trials, the most common adverse reactions (≥ 2% and > placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.

To report SUSPECTED ADVERSE REACTIONS, contact Avanir Pharmaceuticals at 1-844-ONZETRA (1-844-669-3872) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For additional Important Safety Information about ONZETRA, please see full Prescribing Information, including Instructions for Use.