New Study Confirms Long-Term Safety and Tolerability of ZOMIG(R) (Zolmitriptan) Nasal Spray for Treatment of Migraine

SOMERSET, N.J., Jan. 24 /PRNewswire/ — ZOMIG(R) (zolmitriptan) Nasal Spray is well-tolerated for the treatment of migraine during long-term use of up to one year, and its efficacy and tolerability are consistent over study duration, according to results of a new study examining the medication in the treatment of more than 20,000 migraine attacks. Results of the INDEX trial were published in the January issue of Headache, the official journal of the American Headache Society.(1)

“The long-term use and safety record of prescription medications should always be a consideration for physicians when treating patients with recurring conditions such as migraine headache,” said Andrew J. Dowson, MD, Director, King’s Headache Service, King’s College Hospital, London. “The results of this study confirm that ZOMIG Nasal Spray, when used repeatedly by migraine sufferers over a one-year period, was well-tolerated and highly effective in providing relief from headache pain. These data should be of particular value to physicians in the ongoing treatment of their migraine headache patients.”

INDEX was an open-label, noncomparative, multicenter phase III trial that assessed the long-term safety and tolerability of ZOMIG Nasal Spray 5 mg in 538 adult patients who treated 20,717 migraine attacks of any baseline severity during one year. Serious adverse events were very rare (0.1% of attacks), and only three serious adverse events were considered to be drug- related (nausea, vertigo and angina pectoris). The only adverse events to occur in greater than or equal to 4% of attacks were unusual taste (19.0%) and paresthesia (6.8%), but these led to treatment withdrawal in only 0.4% and 0.6% of patients, respectively.

The incidence of adverse events declined over time (43.4% of attacks from 0-90 days; 30.8% from 91-180 days; 28.7% from 181-270 days; 27.1% from 271-360 days; 30.7% at 361 days or later), despite the very low withdrawal rates due to adverse events (4.5% of patients). The incidence of recorded nasopharyngeal events also declined during the study (21.8% of attacks at 0-90 days; 12.8% at 91-180 days; 11.5% at 181-270 days; 11.4% at 271-360 days; 12.2% at 361 days or later). These results suggest that patients who had not previously used a triptan nasal spray soon became familiar with the characteristic sensations of nasal dosing and therefore stopped reporting such sensations as adverse events.

Data from the INDEX study also confirm the efficacy of ZOMIG Nasal Spray. In 20,717 attacks treated, more than half (53.8%) were recorded as pain-free two hours after initial treatment, despite most being treated at moderate or severe baseline intensity. These results were consistent over study duration, with overall two-hour pain-free rates ranging from 51.2% to 55.8%.

About ZOMIG(R) (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.(2) 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<0.0001).(3) This nonoral route of administration and direct absorption from within the nasal cavity are potential benefits for patients requiring rapid relief and for those with nausea, vomiting, or who prefer not to administer an injection. In addition, ZOMIG Nasal Spray is well tolerated (4) and is supplied in an easy-to-use, convenient device.

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(R) (zolmitriptan) Tablets and ZOMIG-ZMT(R) (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).(5)

ZOMIG(R) Tablets, ZOMIG-ZMT(R) Orally Disintegrating Tablets, and ZOMIG(R) 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/.

About MedPointe Pharmaceuticals

MedPointe Pharmaceuticals is a privately held specialty pharmaceutical company located at 265 Davidson Avenue, Suite 300, Somerset, New Jersey, 08873-4120; 732-564-2200. MedPointe specializes in respiratory, allergy, central nervous system, cough-cold, and pediatric products. The company maintains a manufacturing facility in Decatur, Illinois. For more information on MedPointe, visit http://www.medpointepharma.com/.

ZOMIG(R) and ZOMIG-ZMT(R) are registered trademarks of the AstraZeneca group of companies. MedPointe markets and sells ZOMIG in the U.S. in accordance with a marketing distributorship with AstraZeneca Pharmaceuticals.

(1) Dowson AJ, Charlesworth BR, Green J et al. Zolmitriptan nasal spray

exhibits good long-term safety and tolerability in migraine: results

of the INDEX trial. Headache 2005;45:17-24.

(2) 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).

(3) Gawel M, Aschoff J, May A, Charlesworth B. Zolmitriptan 5 mg nasal

spray: efficacy and onset of action in the treatment of migraine:

results from phase I of the REALIZE study. Headache.2005;45:7-16.

(4) 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.

(5) IMS Health MIDAS data, 2004

Contact Information: MCS Public Relations

800-477-9626

Carol Cartwright: carolc@mcspr.com

Noelle Piscitelli: noellep@mcspr.com

MedPointe Pharmaceuticals

CONTACT: Carol Cartwright, carolc@mcspr.com, or Noelle Piscitelli,noellep@mcspr.com, both of MCS Public Relations, 1-800-477-9626

Web site: http://www.mcspr.com/