To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AHS: Orally Disintegrating Zomig (Zolmitriptan) Effective And Convenient In Treating Migraines URL: http://www.pslgroup.com/dg/1D77CE.htm Doctor's Guide June 26, 2000
MONTREAL, QC -- June 26, 2000 -- Clinical data presented at the American Headache Society (AHS) annual meeting show that the Zomig® (zolmitriptan) orally disintegrating ("melt") 2.5-mg tablet is an effective, well-tolerated treatment option for migraine.(1,2) The data further show that the new well-liked orange taste formulation is a more convenient way to reduce migraine pain than conventional tablets.(1,2) The Zomig orally disintegrating tablet is a product of AstraZeneca. "Migraine sufferers want an effective, well-tolerated and convenient treatment option," commented Allan Purdy, M.D., of Queen Elizabeth II Health Sciences Centre in Halifax, Canada. "Through our research, we found that zolmitriptan or Zomig orally disintegrating tablets offer sufferers rapid relief, effectiveness, tolerability and convenience -- especially for the patients who have difficulty swallowing pills or aren't accessible to liquids during the onset of a migraine. This innovative melt formulation allows migraine sufferers the convenience of being able to take their medication without liquids, which means it can be done discreetly and without needing to wait for nausea to subside." An orally disintegrating tablet answers a critical need in the marketplace, as evidenced by the results of a recent national survey conducted by Harris Interactive. The survey revealed that more than three-fifths of women (64 percent) say it is absolutely necessary that pain relief medication can be taken at any time during an attack and still be effective.(3) Respondents considered only efficacy (72 percent) as more important. Furthermore, 61 percent of women felt it was necessary that pain relief medication relieve symptoms quickly.(3) Data presented at the conference were based on two analyses from a randomized, double-blind, placebo-controlled, parallel group trial involving 573 patients. The first analysis was conducted to evaluate migraine headache response and involved 470 patients treating a single, moderate/severe migraine attack (231 randomized to Zomig (zolmitriptan) orally disintegrating tablet; 239 randomized to placebo).(1) Results from the analysis showed that 63 percent of patients taking the Zomig orally disintegrating tablet experienced a headache response at two hours, versus 23 percent of patients randomized to placebo, respectively (p less than 0.0001).(1) The analysis further showed that approximately 27 percent of patients taking Zomig achieved pain-free status at two hours, versus 7 percent of patients randomized to placebo.(1) A second analysis assessed patient preference of the melt formulation versus a conventional tablet.(2) This analysis involved 471 patients between 18 and 65 years of age. All patients had an established diagnosis of migraine. It also compared the tolerability of Zomig and placebo as orally disintegrating tablets during the acute treatment of migraine. Researchers found that nearly 70 percent of patients in the Zomig and placebo groups stated they would prefer to take the melt tablet over a conventional tablet to treat their migraine.(2) In addition, similar proportions of patients in both groups reported that the melt tablet was more convenient and could be taken sooner than conventional tablets.(2) Ninety-two percent of the study participants felt that the melt formulation was easy to handle and 80 percent liked the orange taste of the tablet.(2) "With the wide array of treatment options available today, patients are looking for a convenient and effective medication," said Dr. Purdy. "The new Zomig melt formulation provides both these key advantages, plus ease of use. Overall, Zomig was well tolerated. Adverse events were reported by 63 (27 percent) and 29 (12 percent) zolmitriptan and placebo recipients, respectively. Most reported events were of mild or moderate intensity and of short duration. The most frequently reported events in the zolmitriptan group were asthenia, tightness, somnolence, dizziness and paresthesia (all less than 3.5 percent patients). Somnolence and paresthesia were the most commonly reported adverse events in the placebo group (less than 2 percent patients).(2) The company filed a New Drug Application on May 24 with the U.S. Food and Drug Administration for the Zomig melt formulation. Migraine is a chronic medical condition affecting more than 23 million Americans.(4) Attacks are characterized by severe unilateral head pain lasting from four to 72 hours and often are accompanied by nausea, vomiting and sensitivity to light and/or sound. The condition usually occurs in people between the ages of 25 and 55 and predominantly affects women; however, more than one in every 20 men suffer from migraine.(5) References: (1) Purdy A, Macgregor A, Sawyer J. Zolmitriptan 2.5 mg Orally Disintegrating Tablet for the Acute Treatment of Migraine. Poster presented at the American Headache Society Annual Meeting in Montreal, June 23-25, 2000. (2) Purdy A, Dowson A, Sawyer J. Zolmitriptan 2.5 mg Orally Disintegrating Tablets are Well Tolerated and Preferred Over Conventional Tablets. Poster presented at the American Headache Society Annual Meeting in Montreal, June 23-25, 2000. (3) Women's Health in the New Millennium, Survey of Findings conducted online December 2-7, 1999, by Harris Poll Online. Sample Size = 1,530. (4) Stewart W, Lipton R, Celentano, et al. Prevalence of Migraine Headache in the United States: Relation to Age, Income, Race and Other Sociodemographic Factors. The Journal of the American Medical Association. 1992; 267: 64-69. (5) Lipton R, Stewart W. Managing Your Migraine. Zeneca Pharmaceuticals: 1999. Related Link: Zomig (zolmitriptan) and AstraZeneca. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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