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FDA Approves New Nasal Spray Medication for Migraine Treatment

On January 30th, 2019, the United States Food and Drug Administration (FDA) approved a nasal spray for the treatment of migraine (both with and without aura). Tosymra (sumatriptan nasal spray) is currently only approved for adults.1

How is Tosymra different from other nasal sprays for migraine?

While there are currently other sumatriptan nasal sprays available on the market, Tosymra is different because of the new excipient that it uses to deliver the medication. An excipient is an inactive substance that works as a vehicle to deliver medication and allow the body to absorb the drug.2 The excipient in Tosymra delivers drug quickly and efficiently, with patients absorbing as much medication as they would if they were to have a 4mg sumatriptan injection. This high absorption rate means that the drug can work quicker and patients have faster relief from migraine.1

What are Tosymra side effects?

Like any other medication, Tosymra can have side effects. The most common side effects reported were:1

  • tingling
  • dizziness
  • feeling warm or hot
  • burning feeling
  • feeling of heaviness
  • feeling of pressure
  • flushing
  • feeling of tightness and numbness

Some common side effects related to the nasal spray were:1

  • application site (nasal) reactions
  • abnormal taste
  • throat irritation.

Heart-related side effects

There were also serious heart-related side effects (including heart attacks), that can be deadly. It is recommended that anyone at risk for heart disease (including people who are overweight, have high cholesterol or diabetes, have a family history of heart disease or those who smoke) have routine cardiology tests and be cleared before taking Tosymra.1

Seratonin Syndrome

Tosymra can also cause a condition known as Seratonin Syndrome. If you notice symptoms such as mental changes (like hallucination, agitation or coma), changes in blood pressure or heartbeat, fevers, or muscle issues such as trouble walking or muscle tightness, let your healthcare team know immediately.

How can I access Tosymra?

There is no indication of when Tosymra will be available for purchase. You should talk to your healthcare team, including your pharmacist about Tosymra. If you currently have a prescription for a sumatriptan nasal spray, you will have to get a new one to use Tosymra, because the medications will not be interchangeable. You should also talk to your prescription insurance company about the coverage and copays for Tosymra, as it is a brand-name medication, and may be more expensive.

It is acknowledged that in the United States about 25 to 40% of migraine patients do not have enough migraine control with their current treatment. There is a need for better treatment that patients can use reliably, as migraine can be disruptive or even incapacitating.1 Tosymra may be a step toward a better migraine treatment regimen for some patients.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Migraine.com team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. Rossi K. FDA Approves Migraine Nasal Spray, Sumatriptan. MD Magazine. https://www.mdmag.com/medical-news/fda-approves-migraine-nasal-spray-sumatriptan. Published 2019. Accessed February 2, 2019.
  2. Pharmaceutical Excipients | American Pharmaceutical Review. Americanpharmaceuticalreview.com. https://www.americanpharmaceuticalreview.com/25335-Pharmaceutical-Raw-Materials-and-APIs/25283-Pharmaceutical-Excipients/. Published 2019. Accessed February 2, 2019.

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