ONZETRA™ Xsail™ clinical overview

FAST relief that LASTS with one 22 mg dose6

Significant pain relief over placebo at 30 minutes. Sustained pain relief for many patients through 48 hours.6

 

Clinical overview bar graph
30 min

At 30 minutes, 42% of patients achieved significant pain relief vs 27% on placebo (P = .03)6

68%

At 2 hours, 68% of patients achieved significant pain relief vs 45% on placebo (P = .002)6

STUDY DESCRIPTION
  • A 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
  • Primary endpoint was the percentage of patients with headache relief at 2 hours. All other study endpoints shown here were secondary*

For full study description, see the pivotal study.

 

DOWNLOAD A REPRINT OF
THE PIVOTAL STUDY

DOWNLOAD A REPRINT OF
THE PIVOTAL STUDY

STUDY DESCRIPTION
  • A 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
  • Primary endpoint was the percentage of patients with headache relief at 2 hours. All other study endpoints shown here were secondary*

Full Study Description
Definition: Pain Relief*

 

*Analysis of secondary endpoints not controlled for type I error associated with multiple comparisons.

 

ONZETRA Xsail may reduce the use of rescue medications

63%
Within 48 hours of the initial dose, 63% of patients who used ONZETRA DID NOT USE a rescue medication vs 48% on placebo (P = .02)6
 

The reason that these patients did not use a rescue medication is unknown.

Treatment-emergent adverse events reported by at least 2% of patients in two controlled migraine trials1

ADVERSE EVENT
ONZETRA
22 mg, n = 151
PLACEBO
n = 150
Abnormal taste 20% 3%
Nasal discomfort 11% 1%
Rhinorrhea 5% 2%
Rhinitis 2% 0%

Abnormal taste generally described as mild5,6

In the two 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%).5

There are additional risks associated with the use of ONZETRA Xsail. Please see Important Safety Information below.

No patients
discontinued due to abnormal taste5,6

Abnormal taste generally described as mild5,6

In the two 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%).5

There are additional risks associated with the use of ONZETRA Xsail. Please see Important Safety Information below.

No patients
discontinued due to abnormal taste5,6
 

 

 

Low incidence of triptan sensations5

In clinical trials, triptan sensations were reported in < 2% of attacks treated with ONZETRA; none of these events were serious or led to study discontinuation. These sensations commonly occur after treatment with triptans and are usually non-cardiac in origin. However, ONZETRA Xsail is contraindicated in patients with certain cardiac conditions. Perform a cardiac evaluation in patients with high cardiac risk.

Important Safety Information & Indication

ONZETRA Xsail is contraindicated in patients with:

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.

Important Safety Information & Indication

ONZETRA Xsail is contraindicated in patients with:

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.