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FDA Approves 4mg Sumavel DosePro (sumatriptan injection)

The US Food and Drug Administration (FDA) has approved Zogenix’s supplemental NDA (sNDA) for a 4 mg dose of Sumavel DosePro (sumatriptan injection) Needle-free Delivery System.  Estimated availability of the new dose of Sumavel DosePro is June 2014.

Sumavel DosePro is the injection form of sumatriptan, the active ingredient in Imitrex for migraines. Like Imitrex, it is in the triptan class of medications, along with Zomig, Maxalt, Axert, Relpax, Amerge, and Frova.  Sumatriptan, works by narrowing the blood vessels in the brainstem and works best if it is taken as soon as migraine symptoms appear. It will only treat a headache that has started. It will not prevent a migraine attack or reduce the number of attacks you have.

The Sumavel DosePro injection doesn’t need a needle, but uses a burst of gas to shoot the drug underneath the skin. The 6mg dose of Sumavel DosePro has been available since January 2010 and is approved for use in adults with acute migraines and cluster headaches. It is not approved for prevention of migraines other types of headaches.


  • Mort Man
    6 years ago


    Did you find the 4mg effective? Any thoughts on how soon after onset you must use to be max effective?


  • Editorial Team moderator author
    6 years ago

    Hi Mort Man – In general triptans are most effective when taken as early as possible. It’s particularly helpful to know the signs of prodrome (the first stage of a migraine attack). You can learn more here:

  • Mort Man
    6 years ago

    My bad, I meant to ask about 6mg dose, not 4 mg.

  • Donna Fox
    6 years ago

    My thigh will be happy!

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