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.

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