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New Data Shows Zolmitriptan Provides Fast, Lasting Migraine Relief

SAN FRANCISCO, April 27 /PRNewswire-FirstCall/ -- Results of a new multicenter U.S. study of almost 1,900 patients experiencing more than 3,400 migraine attacks confirm that treatment with ZOMIG® (zolmitriptan) Nasal Spray provides a very fast onset of action and long-lasting relief from migraine headache and associated symptoms. Findings from an open-label trial also presented today demonstrate that patients are satisfied with the migraine relief received from ZOMIG Nasal Spray, with the majority of patients willing to continue its use. Data were presented today at the American Academy of Neurology (AAN) 56th Annual Meeting.

"Many migraine sufferers typically cite fast-acting relief as a high priority in choosing a migraine therapy," said Jan Lewis Brandes, MD, Clinical Instructor, Department of Neurology, Vanderbilt University School of Medicine and head of Nashville Neuroscience Group, and an investigator of the U.S. study. "In this trial, some patients began experiencing relief from their symptoms as early as 15 minutes after using zolmitriptan nasal spray."

Early Efficacy and Excellent Tolerability

Patients treated with ZOMIG Nasal Spray experienced significantly higher headache response rates compared to placebo at 15 minutes postdose (17.0% vs 9.6%, P

ZOMIG Nasal Spray was well tolerated, and the most common adverse event in study patients using ZOMIG Nasal Spray was unusual taste, which was generally considered mild. Few patients in either group withdrew due to adverse events (0.6 % vs 0.3 % with placebo).

REALIZE Phase 2: High Levels of Patient Satisfaction Reported

The new data from the open-label second phase of the large-scale REALIZE (Real Life Intranasal Zolmitriptan Exposure) study, also presented today, was designed to assess patient satisfaction with ZOMIG (zolmitriptan) Nasal Spray and willingness to use this treatment in the future in 851 patients who had participated in Phase 1 of the trial. The majority of patients who used ZOMIG Nasal Spray in REALIZE Phase 2 reported being satisfied or very satisfied with overall effect (76.7%); speed of relief (76.9%); convenience (89.2%); ease of use (92.8%); and reliability (76.7%). The majority of patients would be willing to use it in the future (60.6%). The most common adverse event was dysgeusia (unusual taste, 15.1%), but only 0.2% of patients discontinued treatment due to this side effect.

"The earlier phase of this study demonstrated that intranasal zolmitriptan showed rapid and significant headache response from 10 minutes postdose, the earliest reported for a noninjectable triptan," said Marek Gawel, MD, FRCPC, consulting neurologist, Sunnybrook Women's Health Sciences Centre, Toronto, and lead investigator of the study. "Our follow-up study has shown that patients also are very satisfied with the drug's speed of relief, reliability, convenience, and ease of use."

Efficacy and Tolerability During Long-term Use

Additional data from a third study, the INDEX trial, presented today showed that ZOMIG Nasal Spray was well tolerated and effective over a one-year period. In a study of 538 patients who treated more than 20,000 migraine attacks with ZOMIG Nasal Spray, the most common adverse events were unusual taste (19.0%) and paresthesia (numbness, tingling, burning, prickling, and increased sensitivity, 6.8%). However, only 4.6% of patients withdrew due to adverse events.

A second objective of the trial was to assess efficacy during long-term use of ZOMIG Nasal Spray. In more than half of attacks (53.8%), patients were pain-free at two hours following treatment, an outcome that was maintained throughout the study.

About ZOMIG® (zolmitriptan)

ZOMIG (zolmitriptan) Nasal Spray was approved by the U.S. Food and Drug Administration in September 2003. ZOMIG Nasal Spray is an effective and fast- acting noninjectable triptan therapy. Pharmacokinetic studies show that ZOMIG is detectable in the plasma 5 minutes postdose and in the brain in 5 minutes.(1) In a clinical efficacy and safety study, significant headache relief (defined as severe or moderate pain intensity reduced to mild or none) was seen as early as 10 minutes, and headache response rate at two hours was 65% vs 24% with placebo (P

Zolmitriptan belongs to the class of medications known as triptans, which are selective serotonin receptor agonists. ZOMIG is also available in two other formulations: ZOMIG® (zolmitriptan) Tablets and ZOMIG-ZMT® (zolmitriptan) Orally Disintegrating Tablets. ZOMIG is available in more than 80 countries and is the most prescribed triptan in the top five European markets (France, Germany, Italy, Spain and the UK).(4)

ZOMIG® Tablets, ZOMIG-ZMT® Orally Disintegrating Tablets, and ZOMIG® Nasal Spray are indicated for the acute treatment of migraine with or without aura in adults. ZOMIG is not intended to prevent migraine attacks but to relieve pain regardless of when the migraine 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 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. 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. The most common side effects of ZOMIG Nasal Spray are unusual taste, dry mouth, tingling sensation, skin sensitivity, especially around the nose, pain, pressure, and tightness sensations (eg, in the nose, throat, or chest), drowsiness, weakness, dizziness and nausea.

For full prescribing information, please visit http://www.zomig.com/. References:

1 Wall A, Kagedal M, Nilsson D., Yates R, Langstrom B, Bergstrom M. An open-label positron emission tomography study to investigate the distribution of intranasally administered 11-C zolmitriptan into the CNS. European Journal of Neurology. 2003;10(Suppl 1):S36. (Abstract).
2 Gawel M, Aschoff J, Lee J, Charlesworth BR. Zolmitriptan nasal spray is highly efficacious, very fast-acting and produces sustained relief in the treatment of acute migraine in a real-life setting: Results from phase I of the REALIZE study. Annals of Neurology. 2003;54 (Suppl 7):S32.
3 Dowson AJ, Charlesworth BR, Purdy A, Becker WJ, Boes-Hansen S, Farkkila M. Tolerability and consistency of effect of zolmitriptan nasal spray in a long-term migraine treatment trial. CNS Drugs. 2003;17(11); 839-851.
4 IMS Health MIDAS data; Any analysis of IMS data is independently arrived at by AstraZeneca on the basis of the data and other information. IMS Health is not responsible for any reliance by recipients of the data or any analysis thereof.

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