New Scientific Review Shows That Zolmitriptan ('Zomig(TM)') Nasal Spray Provided Efficacious Relief From Cluster Headache

Main Category: Headache / Migraine
Also Included In: Pain / Anesthetics;  Clinical Trials / Drug Trials
Article Date: 08 Sep 2008 - 2:00 PDT

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Results from a new pooled data analysis presented at the European Headache and Migraine Trust International Congress (EHMTIC) 2008 today show that zolmitriptan ('Zomig') nasal spray provided fast and efficacious relief in the treatment of episodic and chronic cluster headache. The data shows that zolmitriptan nasal spray provided significant relief from cluster headache at 30 minutes - this maybe of real significance for patients whose current treatment options (oxygen inhalation, self administered sumatriptan injection or a combination of both) are limited due to inconvenience of use.

Zolmitriptan nasal spray has recently been approved in the Netherlands, Denmark and Germany by their national licensing authorities for the acute treatment of cluster headache, but is not yet licensed in the United Kingdom.

Cluster headache is characterised by recurrent, short-lasting headache attacks with rapid onset of excruciating pain. It has been reported to be the most painful type of headache, even compared with migraine and tension-type headaches. Female sufferers have reported that the pain of each attack is worse than childbirth.

Data from the meta-analysis of two double-blind, randomised, cross-over studies involving 121 evaluable adult patients shows that zolmitriptan nasal spray provided significant cluster headache relief at 30 minutes compared to placebo at both 5 mg and 10 mg doses, meeting the primary endpoint of the study. The odds ratios (OR) for 5 mg versus placebo is 3.48 (CI: 1.49, 8.10, p=0.004) and for 10 mg versus placebo is 8.68 (CI: 3.35, 22.5, p<0.001).

For the subpopulation with episodic cluster, the headache response rates were 35.6%, 51.7% and 73.7% for placebo, 5 mg and 10 mg respectively. The OR was 2.5 (p=0.06) for 5 mg and 9.9 (p<0.001) for 10 mg vs. placebo. For the patients with chronic cluster, the headache response rates were 17.2%, 41.9% and 40.7% for placebo, 5 mg and 10 mg respectively. The OR was 8.1 (p=0.035) for 5 mg and 7.6 (p=0.046) for 10 mg.

Adverse event rates were slightly enhanced with zolmitriptan nasal spray 10 mg versus 5 mg and were higher with both doses compared to placebo. Overall, the most frequently reported adverse events with zolmitriptan nasal spray (i.e. in 1 patient) were dysgeusia, nausea, dizziness, headache, somnolence, chest discomfort, fatigue and vomiting.

"Zolmitriptan nasal spray offers cluster patients an important, new and evidence-based option for the treatment of what can be devastatingly severe pain. The data draw attention to a neurological disorder that is relatively common and often under-treated. The studies have come from a productive collaboration of European and US headache centres with the active participation of patients that will make a real difference for those affected by this horrible problem," comments Professor Peter Goadsby from Department of Neurology, University of California, San Francisco, who co-ordinated the study from the Institute of Neurology, London, UK.

Study design

A total of 64.5% of patients had episodic cluster headache and 35.5% had the chronic form. Patients treated up to three cluster headache attacks with zolmitriptan nasal spray 5 mg, 10 mg or placebo. Headache intensity was rated by a five-point scale: none, mild, moderate, severe and very severe. The primary endpoint was headache relief after treatment at 30 minutes (defined as a reduction from moderate / severe / very severe to mild or none).

About cluster headache

It affects about one to three per 1000 people , and is about three times more common in men than in women. Typical onset of cluster headache is between the age of 28 and 30 years.

There are generally two types of cluster headache:

- Episodic cluster headache, the most common type (almost 80% of patients, defined as at least two cluster periods lasting 7 to 365 days and separated by pain-free remission periods of one month or more

- Chronic cluster headache, defined as attacks recurring over more than one year and either no pain-free remission, or the remission period lasts less than one month

Cluster headache is a condition which is frequently under-diagnosed and often goes untreated. There is currently no cure for cluster headache; however, a number of treatment options are available to provide relief from this painful and debilitating condition.

About 'Zomig'

'Zomig' is licensed for the acute treatment of migraine with or without aura in adults. 'Zomig' Nasal Spray received approval for the acute treatment of cluster headache in the Netherlands, Denmark and Germany, but is not yet licensed in the United Kingdom.

For acute migraine treatment there are three 'Zomig' formulations ('Zomig' classic oral tablets, 'Zomig Rapimelt' and 'Zomig' Nasal Spray) which are highly effective and well tolerated,(10) providing patients a choice of three formulations that allow treatment to be tailored to their needs and preferences. They have been used to treat patients in over 80 countries throughout the world. 'Zomig' Nasal Spray 5 mg was first launched in 2002 and provides a headache response statistically superior to both placebo and the 2.5 mg 'Zomig' tablet as early as 15 minutes

'Zomig' and 'Zomig Rapimelt' are trademarks of the AstraZeneca group of companies.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

AstraZeneca