The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: GlaxoWellcome
Approval Status: Approved November 1997
Treatment for: migraine
General Information
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.
Clinical Results
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 mg).
Side Effects
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.
