Onzetra Xsail

What is Onzetra Xsail?

Onzetra™ Xsail™ (sumatriptan), formerly called AVP-825, is a new treatment option available for people living with migraine. In January 2016, the US Food and Drug Administration approved Onzetra Xsail for use by adults who have migraine with or without aura. It is an acute treatment, meaning that it is only for quickly treating an ongoing migraine attack. It is not designed for the prevention of migraine, and the medicine is available only by prescription.

How does Onzetra Xsail work?

The active ingredient in Onzetra Xsail is sumatriptan, which has been used in popular migraine medications for years.  In Onzetra Xsail, sumatriptan is delivered into the body through the nose in the form of a powder. Patients use a new kind of handheld device to take the medicine, which has both a mouthpiece and a nosepiece that is placed into one of the nostrils.

To take the medicine, you exhale strongly into the mouthpiece, which has the effect of closing off the soft palate in the back of the mouth. This allows all of the powder in the inhaler to be delivered deep into the nasal passage by the force of the breath, and prevents the powder from being accidently swallowed or inhaled. There are many small blood vessels in the back of the nose where the medicine can be absorbed quickly and carried through the bloodstream throughout the body.

How effective is Onzetra Xsail?

Onzetra Xsail may be recommended for people who have cycled through many different kinds of medicines for acute migraine treatment, and need a new option that may offer quick, longer lasting relief. It may be suitable for people who:

  • Have nausea during a migraine attack
  • Wake up with migraine
  • Have migraine that gets worse quickly

To test the effectiveness of Onzetra Xsail, clinical studies were carried out in which half of the patients took Onzetra Xsail to treat a moderate or severe migraine, and the other half took a placebo (which contained no active ingredient). The results of the study revealed that among the patients who took Onzetra Xsail:

  • Around 42% reported significant pain relief after 30 minutes (compared to 27% of patients who took the placebo)
  • Around 68% reported significant pain relief after 2 hours (versus 45% of patients who took the placebo)
  • After 48 hours, around 63% reported that they did not need to take another dose either or Onzetra Xsail or of any other migraine medication (compared with 48% of patients who took the placebo)

Who can take Onzetra Xsail?

Onzetra Xsail is approved only for the treatment of adults who have migraine with or without aura. It is not yet known if it is safe for people under the age of 18 or for women who are pregnant or breastfeeding. It is not suitable for people who are allergic to sumatriptan.

Before prescribing Onzetra Xsail, healthcare providers need to know if you have:

  • Current or past heart problems
  • Had any kind of stroke or blood circulation problems, including peripheral vascular disease
  • High blood pressure that is not controlled with medicine
  • Hemiplegic or basilar migraine
  • Ischemic bowel disease, which affects blood supply to the digestive system
  • Severe liver problems

Healthcare providers will also ask if you have taken any other kind of migraine medicine in the previous 24 hours, or if you are taking a medicine called a monoamine oxidase inhibitor (MAOI).

What side effects can Onzetra Xsail cause?

During the study to test its effectiveness, the most common side effects reported by people taking Onzetra Xsail were:

  • A mild metallic taste (20% of patients)
  • Nasal discomfort (11% of patients)
  • Runny nose (5% of patients)
  • Stuffy nose (2% of patients)

Taking Onzetra Xsail can also cause some very serious side effects for a small number of people. It can cause heart attack and other dangerous heart problems. Stop using the medicine and get medical help immediately if you have any symptoms of a heart attack, such as shortness of breath or a feeling of tightness, pain, pressure, or heaviness in the chest, throat, neck, or jaw.

A small number of people who take Onzetra Xsail at the same time as certain types of anti-depressant medicines may develop a rare condition called serotonin syndrome. Talk to a healthcare provider if you develop any of the following symptoms:

  • Mental changes such as hallucinations or feeling agitated
  • Coma
  • Fast heartbeat
  • Blood pressure changes
  • High body temperature
  • Muscle tightness
  • Trouble walking
  • Nausea, vomiting, or diarrhea

Other serious side effects that Onzetra Xsail can cause include:

  • Raynaud’s syndrome, which affects blood circulation in the fingers and toes
  • Stomach and digestive problems
  • Blood circulation problems in the legs and feet (peripheral vascular ischemia)
  • Seizures
  • Taking Onzetra Xsail too often can cause medication overuse headaches.
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