Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Neurology | Family Medicine
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Imitrex (sumatriptan) nasal spray
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved November 1997
Treatment Area: migraine
The nasal spray form of Imitrex (sumatriptan) for the treatment
of migraine has been approved for marketing. Imitrex has been
available in the U.S. since 1993 in injection form, and since 1995
in tablet form.
Imitrex Nasal Spray is indicated for the acute treatment of
migraine attacks in adults with or without aura. Imitrex Nasal
Spray is not intended to prevent or reduce the number of migraine
attacks, nor is it for use in the management of basilar or
hemiplegic migraine. Imitrex should only be used where a clear
diagnosis of migraine headache has been established.
Imitrex, a nonsedating, nonnarcotic medication, is the only
migraine therapy that treats the multiple symptoms characteristic
of migraine, including severe recurrent pain usually on one side of
the head often accompanied by one or more of the following: nausea
and sensitivity to light and sound. Imitrex is equally effective
when taken at any point during a migraine headache.
Imitrex Nasal Spray has been studied in clinical trials with
more than 3,700 patients to treat more than 10,000 attacks. In
these studies, 55% to 64% of patients achieved headache relief at
two hours with a 20 mg dose.
In four out of five studies, there was a significantly greater
percentage of patients with headache response at two hours in the
20 mg group when compared with the lower dose groups (5 mg and 10
In clinical trials for the 20 mg nasal spray formulation, the
most common side effects included bad/unusual taste, and nausea
and/or vomiting. Most side effects are mild and transient.