Chemical structure of sumatriptan
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Imitrex

Sumatriptan (Imitrex®, Imigran®) is a triptan drug originally developed by Glaxo for the treatment of migraine headaches. Several dosage forms for sumatriptan have been approved, including tablets, solution for injection, and nasal inhalers. Sumatriptan was the first triptan available (in 1993), and is available only by prescription in the United States. more...

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Mode of action

Sumatriptan is a 5-HT (5-HT1D) agonist. The specific receptor subtype it activates is present in the cranial and basilar arteries. Activation of these receptors causes vasoconstriction of those dilated arteries. Sumatriptan is also shown to decrease the activity of the trigeminal nerve.

Pharmacokinetics

Sumatriptan is administered in several forms; tablets, subcutaneous injection, and nasal spray. Oral administration (as succinate) suffers from poor bioavailability, partly due to presystemic metabolism — some of it gets broken down in the stomach and bloodstream before it reaches the target arteries. A new rapid-release tablet formulation has the same bioavailability, but the maximum concentration is achieved on average 10-15 minutes earlier. When injected, sumatriptan is faster acting (usually within a minute), but the effect lasts for a shorter time. Sumatriptan is metabolised primarily by monoamine oxidase A into an indole acetic acid analogue, part of which is further conjugated with glucuronic acid. These metabolites are excreted in the urine and bile.

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Migraine drug approved - Imitrex
From FDA Consumer, 3/1/93

People who suffer the acute pain of migraine headaches may find relief with a new injectable drug FDA approved Dec. 28. 1992, called Imitrex (sumatriptan).

In two clinical trials in the United States involving more than 1,000 patients with acute migraine headaches, a 6-milligram injection of Imitrex relieved the pain in 75 percent of the patients within one hour. A few felt pain relief within 10 to 30 minutes, and 80 percent of the patients felt pain relief after two hours.

Although effective in alleviating pain in a high proportion of patients, Imitrex is not a cure for migraines. In addition, people with underlying heart disease should not take the drag because it may constrict coronary arteries.

"FDA advises, as a precautionary measure in people who might have underlying coronary artery disease, that physicians consider giving the first injection in their Office," says Carl Peck, M.D., director of FDA's Center for Drug Evaluation and Research. "This will allow patients to be observed and treated for adverse reactions, if necessary."

Peck said that having the first injection given by a doctor would also ensure proper use of the auto-injector. The device injects the maximum recommended dose of 6 milligrams under the skin.

Patients who need a lower dose will get a separate syringe and single-dose vial.

The drug's side effects include a mild, short-lived rise in blood pressure, fatigue, and drowsiness.

Educational information, including a videotape and patient brochure, on how to use the automatic injection device and the injectable vials will be provided to physicians and their patients.

The patient brochure advises women of childbearing age to consider carefully the benefits and risks of using Imitrex. In animal studies, fatal deaths occurred in rabbits, but not in rats, given the drug. As part of extensive post-marketing studies, the manufacturer will collect data on women who become pregnant while on the drag.

Imitrex is manufactured by Glaxo, Inc., Research Triangle Park, N.C.

(For more information on migraines and other headache pain, see "Migraine, Cluster and Tension: Headache Misery May Yield to Proper Treatment in the September 1992 FDA Consumer.)

COPYRIGHT 1993 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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