Zolmitriptan (Zomig) Nasal Spray Rapidly Relieves Agony Of Cluster Headache

Main Category: Headache / Migraine
Article Date: 04 Jul 2007 - 11:00 PDT

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Results from a new study presented at the 13th Congress of the International Headache Society (IHC) today show that zolmitriptan ('Zomig') 10mg nasal spray provides rapid relief from the excruciating pain of cluster headache, a condition recognised as one of the most painful known to mankind, at 10 minutes vs. placebo.1

The headache response data show that acute treatment with zolmitriptan nasal spray significantly relieves cluster headache at 30 minutes at 5mg and 10mg doses when compared to placebo.

"Cluster headache is sometimes known as 'suicide headache' because the pain is so intense that some patients contemplate taking their lives if they cannot find relief. The attacks begin suddenly and the intensity builds rapidly. Currently the only effective acute treatments are either an injection of sumatriptan or the inhalation of 100% oxygen. But both of these are somewhat inconvenient for the patient", comments study investigator Dr Alan Rapoport, Clinical Professor of Neurology at the David Geffen School of Medicine at UCLA, Los Angeles, California and co-founder and Director-Emeritus of The New England Center for Headache, Stamford, Connecticut, US. "This new data is very significant as it shows that zolmitriptan nasal spray is rapidly effective and tolerable in the acute treatment of cluster headache. This opens the door to a new, more convenient treatment option in the future."

The multicentre, double-blind, randomised, three-period, crossover, outpatient study involved 55 patients who were treated for 145 attacks. Patients treated each of their headaches with zolmitriptan nasal spray 5mg, 10mg (2 x 5mg) and placebo. Headache intensity was rated by a five-point scale: none, mild, moderate, severe and very severe. The primary efficacy measure was headache response (defined as a reduction from moderate / severe / very severe headache to mild or none) at 30 minutes.

The results show that both doses of zolmitriptan nasal spray provide significant relief in cluster headache. 52% of patients receiving zolmitriptan nasal spray 5mg and 60.8% of patients receiving zolmitriptan nasal spray 10mg reached the primary endpoint compared to 34% of patients who received placebo. For headache relief, zolmitriptan nasal spray 10mg was seen to start working as early as 10 minutes (30.6% vs. 18% compared to placebo). Headache relief for zolmitriptan nasal spray 5mg was significantly more effective than placebo at 15 minutes (30.6% vs. 14%). In addition, 15.2% of patients receiving zolmitriptan nasal spray 10mg reached pain-free status at 10 minutes, compared to only 2% of patients receiving placebo.

Side effects were mild and seen in 12% of those receiving placebo; 26.5% of attacks treated with zolmitriptan nasal spray 5mg and 28.2% of attacks treated with zolmitriptan nasal spray 10mg (p < 0.05).

This new research confirms the results of a previous European, placebo-controlled, double-blind, cross-over study involving 92 cluster headache patients which showed that both 5mg and 10mg doses of zolmitriptan nasal spray are effective within 30 minutes and well tolerated in the acute treatment of cluster headache.2

About Cluster Headache2

Cluster headache is characterised by recurrent, short-lasting headache attacks with rapid onset of excruciating pain. It is the most painful type of primary headache2 and female sufferers have reported that the pain of each attack is worse than childbirth.3

Attacks last from 15 minutes to three hours and are accompanied by one of the following: conjunctival injection (redness) or lacrimation (tearing); nasal congestion or rhinorrhoea; eyelid oedema; forehead/facial sweating; miosis (pupilliary constriction) or ptosis (drooping eyelids). Cluster headache is also associated with a sense of restlessness or agitation. It affects about 1 in 1000 people and is about four times more common in men than in women. Typical onset of cluster headache is between the age of 20 and 50 years. There are two types of cluster headache:

-- Episodic cluster headache, the most common type, defined as at least two cluster periods lasting seven 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.4

There is currently no cure for cluster headache and, since attacks are very short lived, painkillers in tablet formulation are not effective because the tablets take too long to be absorbed into the body. Non-oral treatment options are more appropriate because they can start to treat the pain quickly due to their more rapid absorption.5

'Zomig' - Ten Years of Relief

This year marks the 10th anniversary of the launch of 'Zomig' for acute migraine treatment. Since launch in 1997, more than 400 million doses have been sold worldwide. 'Zomig' sales top $1 million a day, with cumulative sales of more than $2.9 billion6, making it a true 'blockbuster' pain-relief therapy.

The three 'Zomig' formulations ('Zomig' classic oral tablets, 'Zomig Rapimelt' and 'Zomig' Nasal Spray) are highly effective and well tolerated acute migraine treatments, providing patients a choice of three formulations that allow treatment to be tailored.7 They have been extensively used to treat patients in over 80 countries throughout the world. 'Zomig' Nasal Spray 5.0 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.8

'Zomig' is licensed for the acute treatment of migraine with or without aura in adults. 'Zomig' is not currently licensed for the treatment of cluster headache. 'Zomig' and 'Zomig Rapimelt' are trade marks of the AstraZeneca group of companies.

AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

AstraZeneca Neuroscience - Building on a 10 Year Heritage

Neuroscience is a key therapeutic area for AstraZeneca. In Neuroscience, the company is dedicated to providing medicines that have the potential to change patients' lives. 2007 marks the 10th anniversary of the launch of two market leading products from AstraZeneca Neuroscience: 'Zomig' for the acute treatment of migraine treatment and 'Seroquel' for the treatment of schizophrenia and the treatment of acute mania associated with bipolar disorder.

The company also markets the world leading anaesthetics 'Diprivan' and 'Xylocaine' as well as the more-recently introduced 'Naropin' long-acting local anaesthetic. The AstraZeneca Neuroscience pipeline includes new approaches for the treatment of depression and anxiety, Alzheimer's, multiple sclerosis, cognitive disorders, and pain control.

References

1. IHC 2007 abstract # F020
2. Cittadini E, May A, Straube A, Evers S, Bussone G, Goadsby P J Effectiveness of Intranasal Zolmitriptan in Acute Cluster Headache, Arch Neurol. 2006;63(doi:10.1001/archneur.63.11.nct60002)
3. Matharu MS, Goadsby PJ. Cluster headache: focus on emerging therapies. Expert Rev Neurother. 2004 Sep;4(5):895-907
4. Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders. 2d ed. Cephalalgia 2004;24(suppl 1):9-160.
5. www.clusterheadaches.org.uk. 2007
6. Astrazeneca internal 'SCORE' sales data May 2007
7. Smith TR, Headache Care 2004;1(3):1-12
8. Charlesworth et al, CNS Drugs 2003;17(9):653-67

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