To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Approves Axert (Almotriptan malate) for Acute Treatment of Migraine URL: http://www.pslgroup.com/dg/1FA3FE.htm Doctor's Guide May 8, 2001
PEAPACK, NJ -- May 8, 2001 -- Pharmacia Corporation announced yesterday that the U.S. Food and Drug Administration (FDA) has approved Axert ™ (almotriptan malate tablets) for the acute treatment of migraine with or without aura in adults. Axert represents an important new addition to available therapies for the estimated 28 million Americans who suffer from migraine, primarily women. Controlled studies confirm that Axert is highly effective and well-tolerated. In these studies, the percentage of patients achieving a response (mild or no pain) two hours after treatment was significantly greater in patients who received either Axert 12.5 mg or 6.25 mg, compared with those who received placebo. Additionally, in these studies the incidence of side effects reported was low and similar to placebo. "The solid performance profile of Axert, with its strong efficacy plus its favorable side effect profile, will make it a new treatment option for physicians and patients," said principal investigator Egilius L.H. Spierings, M.D., Ph.D., associate clinical professor of neurology at Harvard Medical School and general medical director of the Boston Clinical Research Center. "A therapy that offers these multiple benefits may improve patient compliance and overall satisfaction with migraine management." Approximately 10 percent of the U.S. population suffer from migraines. More than 112 million workdays are lost each year as a result of migraine, costing employers $13 billion annually due to missed work and diminished on-the-job function. Migraine is one of the top 10 reasons for outpatient physician visits, and migraine sufferers visit emergency rooms four times as often and require three times as many prescriptions as non-sufferers. "We are excited to enter the migraine treatment marketplace with Axert," said Nancy Lurker, Group Vice President, Pharmacia Corporation. "Migraine is a devastating and costly health condition in the United States, and we're confident Axert will benefit sufferers." The recommended dose of Axert is one 12.5 mg or 6.25 mg tablet. Axert is not intended for prophylactic therapy of migraine. Safety and effectiveness of Axert have not been established for cluster headache, which is present in an older, predominantly male population. The most common side effects reported with Axert 12.5 mg. were nausea (2 percent vs. 1 percent with placebo), dry mouth (1 percent vs. 0.5 percent with placebo) and paresthesia, which is a feeling of numbness or tingling (1 percent vs. 0.5 percent with placebo). In controlled studies, Axert was shown to have a low percentage of side effects that are associated with triptans, such as chest discomfort and chest pain. However, because of the potential of this class of compounds to cause coronary vasospasm (the sudden spasm of a blood vessel), Axert should not be given to patients with documented ischemic or vasospastic coronary artery disease.
SOURCE: Pharmacia Corporation
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