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| |  Migraine Treatment, Zomig (Zolmitriptan) Nasal Spray, Now Available in US WILMINGTON, DE -- October 1, 2003 -- AstraZeneca (NYSE: AZN) today announced the launch of Zomig® (zolmitriptan) Nasal Spray (5.0, 2.5, 1.0, 0.5 mg) as a fast-acting treatment option(2) for the 28 million Americans who suffer from migraine.(3) Approved by the U.S. Food and Drug Administration (FDA) on October 1 for the acute treatment of migraine with or without aura in adults, Zomig Nasal Spray provides migraine relief as early as 15 minutes and increasing efficacy up to two hours.(2) That attribute is an important consideration for migraine sufferers, as indicated in a new national survey -- conducted by the American Council for Headache Education (ACHE) and AstraZeneca -- in which 62 percent of female migraineurs claim a top priority for migraine medications is fast relief from migraine pain (within 15-30 minutes).(1) Zomig Nasal Spray is thought to have a rapid onset of action by virtue of its excellent nasokinetic profile, by which approximately 30 percent of the dose is absorbed directly through the nasal mucosa (the mucous membranes inside the nose).(2) The rapid onset of action was evident in a pivotal clinical trial in which a significant headache response was seen at 15 minutes in 11 percent of attacks treated with 5 mg of Zomig Nasal Spray and in 11 percent of attacks treated with the 2.5 mg dose, compared to 5.0 percent in patients treated with placebo.(2) Additionally, a significantly greater headache response was achieved at two hours for all doses of Zomig Nasal Spray compared with placebo, with response rates of 69 percent, 59 percent, 59 percent and 40 percent for the 5.0, 2.5, 1.0 and 0.5 mg doses of the nasal spray, respectively, compared with 31 percent for placebo.(2) "One of the most common complaints I hear from patients with migraine is that available treatments do not act quickly enough," commented Rose Giammarco, M.D., Associate Clinical Professor at Charlton Medical Center in Hamilton, Ontario, Canada. "Zomig Nasal Spray should fill the need for effective, rapid relief of migraine symptoms, particularly for the many patients who experience nausea or vomiting in conjunction with their migraine attacks." The need for fast-acting migraine relief was highlighted in the ACHE/AstraZeneca survey of 405 American women between the ages of 25 and 55 (the data were weighted to reflect the U.S. population of females age 25-55).(1) According to the survey, approximately one in every five women (19 percent) in this age group suffers from migraines or severe headaches that interfere with one's ability to work and enjoy life.(1) Whereas the vast majority (93 percent) of female migraineurs take medication for their pain, one out of five (20 percent) react to medication with nausea and vomiting.(1) Zomig Nasal Spray is the first nasal spray of its kind to be developed in nearly six years. In the ACHE/AstraZeneca survey, 47 percent of respondents who have tried other nasal sprays for migraine treatment report being dissatisfied with the medication, and another 35 percent say they were only "somewhat satisfied" with the nasal spray they tried.(1) Of those who stopped taking a nasal spray, 42 percent cite lack of efficacy as the primary reason, and 22 percent cite bad taste or nausea as the reason for discontinuing a previous nasal spray medication.(1) MORE SURVEY RESULTS The ACHE/AstraZeneca survey also found: * On average, female migraineurs have been experiencing about five migraines or severe headaches per month (5.2) and have been suffering for a long time -- six years or more (59 percent).(1) * Most sufferers have experienced migraine pain in the morning (66 percent), as well as nausea or vomiting from their episodes (87 percent).(1) * Over a typical three-month time period, migraine sufferers miss, on average, about nine days of work or school, or of engaging in social or leisure activities, or of performing household chores. During the same time period, sufferers' productivity -- whether at work, school or home -- is cut at least in half for an average of eight days.(1) ABOUT Zomig Zomig® Nasal Spray is the newest addition to the Zomig product line, joining the conventional tablet, Zomig® (zolmitriptan) Tablet and the orally disintegrating tablet, Zomig-ZMT® (zolmitriptan), Orally Disintegrating Tablets. The Zomig family of formulations offers healthcare providers and patients a wide array of effective options in the treatment of migraine. Zomig (zolmitriptan) Tablets, Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets and Zomig(zolmitriptan) Nasal Spray are indicated for the acute treatment of migraine with or without aura in adults. Zomig is not intended to prevent attacks from happening but to relieve pain regardless of when the attack occurs. Zomig is contraindicated for patients with uncontrolled hypertension, ischemic heart disease, or other significant underlying heart disease. In addition, Zomig should not be administered to patients who are hypersensitive to zolmitriptan or any of the inactive ingredients of Zomig. Zomig is not intended for the prophylactic therapy of migraine or for the use of the management of hemiplegic or basilar migraine. Zomig should not be taken by patients who have certain types of heart disease or uncontrolled high blood pressure. Very rarely, some people without recognized heart disease may have serious heart-related problems. Also patients who think they may have risk factors for heart disease such as smoking, high blood pressure, high cholesterol, or a family history of heart disease, or if they are pregnant, nursing, or taking medications, should talk to their healthcare provider. Phenylketonuric patients should be informed that Zomig-ZMT contains phenylalanine, a component of aspartame. The most common side effects associated with taking oral Zomig include dizziness; tightness, pressure or pain in the neck, throat, or jaw; fatigue; tingling sensations; drowsiness; and nausea. For more information about Zomig or to obtain a copy of the Prescribing Information, please call 800-236-9933, or access our Web site at http://www.astrazeneca-us.com or http://www.zomig.com. REFERENCES (1) Migraine Medication Study conducted by International Communications Research (ICR). December 2002. (2) Package Information for Zomig® Nasal Spray. (3) Lipton, R, Diamond S, Reed M, Stewart W. The Burden of Migraine: Compelling Insights from the American Migraine Studies. Consultant. September 2000. (Supplement). (4) Osterhaus J, Gutterman D, Plachetka J. Healthcare resource and lost labour costs of migraine headache in the US. PharmacoEconomics. 1992; 2:67-76. (5) Rapoport A, Adelman J. Cost of Migraine Management: A Phamacoeconomic Overview. The American Journal of Managed Care.1998;4:531-545.
SOURCE: AstraZeneca
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