To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Axert (Almotriptan Malate) Tablets Available In United States URL: http://www.pslgroup.com/dg/2030CA.htm Doctor's Guide August 8, 2001
PEAPACK, N.J. -- August 8, 2001 -- Axert™ (almotriptan malate tablets)-a new treatment option that offers highly effective relief and has few side effects-is now available by prescription from physicians nationwide for the acute treatment of migraine with or without aura in adults. Axert received approval from the U.S. Food and Drug Administration (FDA) in May 2001. Medication side effects pose a problem for some sufferers. In fact, a new survey commissioned by Pharmacia and conducted by the National Headache Foundation(1) found two out of three sufferers have delayed taking their medications or have skipped doses altogether due to side effect concerns, reinforcing the need for new treatment options.
"Axert is an important first-line option for the treatment of migraine," said Michael Gallagher, D.O., Director of the University Headache Center at the University of Medicine and Dentistry of New Jersey School of Osteopathic Medicine. "Many sufferers who endure these often crippling headaches will find Axert is very effective and reliable and also well tolerated, which is a good combination."
In clinical 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 were low and similar to placebo. Axert is not intended for prophylactic treatment of migraine.
Migraine affects roughly 12 percent of the U.S. population, and the disease strikes women three times more often than men. Migraine is one of the top 10 reasons for outpatient physician visits, and costs from missed work and reduced productivity are estimated at $13 billion annually.
Axert is available in 12.5 and 6.25 mg. tablets. Axert should only be used where a clear diagnosis of migraine has been made. 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 such as chest discomfort and chest pain compared with placebo.
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 or other significant underlying cardiovascular disease.
Pharmacia Corporation is marketing Axert in the United States under a licensing agreement with the drug's innovator, Almirall Prodesfarma, S.A., Spain. Almotriptan currently is approved in the European Union, and has been marketed in Spain since September, 2000.
(1) National Headache Foundation Survey, "Medication Related Side Effects, Concerns, and Impact Among Migraine Sufferers"; February 2001.
SOURCE: Pharmacia Corporation
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