ZOMIG EFFECTIVE IN TREATMENT OF EPISODIC CLUSTER HEADACHE.

Study results recently published in Neurology found that ZOMIG(R) (zolmitriptan) Tablets, a medication developed for the treatment of migraine, is effective in the acute treatment of episodic cluster headache. The study results demonstrated that more than half of patients taking ZOMIG experienced headache response after just 30 minutes (ZOMIG 46.8 percent vs. placebo 28.9 percent).

Cluster headache attacks are unique in that they usually last from 15 minutes to three hours and can occur more than once a day. Most patients have episodes in which the attacks occur at discrete intervals lasting weeks or months interspersed with periods of complete remission. The headaches occur most often at night, and are possibly more painful than any other type of headache. The pain of a cluster headache has been described as piercing, burning, throbbing, pulsating, and so excruciating that most victims cannot sit still and feel compelled to rock in a chair, walk back and forth or bang their heads against something. Cluster headache is five times more common in men than women.

The severity and brevity of cluster headache attacks demand swift, abortive therapy.(1 )As a result, sufferers want a medication with a quick onset of efficacy. Previously, the only options for quick relief from cluster headache came in the form of an injectable medication - an invasive treatment option that many patients consider unfavorable, or, provision of 100 percent oxygen to the patient, which is not always practical.

"People who suffer from episodic cluster headaches have less options with regard to pain treatment than migraineurs," said Professor P.J. Goadsby, National Hospital for Neurology and Neurosurgery, London. "These patients need a medication that can relieve pain as quickly as possible. As these clinical study results demonstrate, zolmitriptan is the first oral triptan to provide rapid onset for patients who experience this unique, debilitating kind of headache."

"Taking a tablet is much more convenient - and preferable - for many patients," said Professor Goadsby. "With oral zolmitriptan, doctors now have an effective, less invasive option to effectively treat their patients' pain."

STUDY DESIGN AND RESULTS

The randomized, multicenter, double-blind, three-period, crossover study of outpatients with episodic or chronic cluster headache involved 153 patients who were recruited by 13 centers in Canada, UK and Sweden. Eligible patients were required to have had cluster headache for at least three months before the start of the study. Patients were randomized to receive placebo and ZOMIG(R) (zolmitriptan) 5 mg and 10 mg tablets to treat three headaches of moderate, severe or very severe intensity. Headache intensity was rated according to a five-point scale.

An analysis of 124 subjects showed that, in patients with episodic cluster headache, ZOMIG 10 mg produced a significantly greater headache response rate (defined as a two point or greater reduction from baseline) than placebo after 30 minutes.(1 )The headache response rate for patients treated with ZOMIG 5 mg tablets was not significantly different from the placebo group.

Asignificantly greater proportion of patients achieved mild or no pain at 30 minutes - meaningful headache response - and experienced a reduced requirement for escape medication when taking ZOMIG 10 mg or 5 mg compared with placebo (77 percent, 78 percent and 55 percent, respectively; both p<0.01 versus placebo). Further, ZOMIG 10 mg and 5 mg were well-tolerated.

Adverse events were reported by 39 percent of patients treated with ZOMIG 10 mg, 28 percent of patients treated with ZOMIG 5 mg, and 15 percent of patients treated with placebo. The most frequently reported adverse events were paresthesia, heaviness, asthenia nausea, dizziness and (non-chest) tightness.

ABOUT ZOMIG AND ASTRAZENECA

ZOMIG(R) (zolmitriptan) conventional tablets are indicated for the acute treatment of migraine with or without aura in adults. ZOMIG is not intended to prevent migraine. ZOMIG is intended to relieve migraine pain at any time during a migraine attack. 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 Tablets. 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, if patients 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, patients should talk to their healthcare provider. The most common side effects associated with taking ZOMIG include dizziness; tightness, pressure or pain in the neck, throat, or jaw; fatigue; tingling sensations; drowsiness; or nausea.

AstraZeneca (NYSE:AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is a $7.4 billion healthcare business with approximately 9,500 employees.