New Scientific Review Shows That Zolmitriptan (...

LONDON, September 7 /PRNewswire/ --     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.(1) 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.(2) Female sufferers have reported that the pain of
each attack is worse than childbirth.(3)



    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).(1)



    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.(1)



    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.(4)



    "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 (5),(6) and is
about three times more common in men than in women.(7) Typical onset of
cluster headache is between the age of 28 and 30 years.(5)


    
    There are generally two types of cluster headache:

    - Episodic cluster headache, the most common type (almost 80%
      of patients(7), 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(8)





    Cluster headache is a condition which is frequently under-diagnosed and
often goes untreated.(9) 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.(11) 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 (10) 



    '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. For more Information visit http://www.astrazeneca.com.



AstraZeneca Neuroscience

    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. The company also markets:


    
    - 'Diprivan' and 'Xylocaine' anaesthetics
    - 'Naropin' a long-acting local anaesthetic
    - 'Seroquel' for the treatment of schizophrenia and the
      treatment of acute mania associated with bipolar I disorder





    The AstraZeneca Neuroscience pipeline includes new approaches for the
treatment of depression and anxiety, Alzheimer's, multiple sclerosis,
cognitive disorders, and pain control.



    For further information, please visit 
http://www.astrazenecapressoffice.com 



    
    C15602 DoP Aug 08
    References
    (1) Hedlund C, Rapoport A, Goadsby P. Zolmitriptan nasal spray in the
        acute treatment of cluster headache: a meta-analysis of two
        double-blind, placebo-controlled, randomized, cross-over studies.
        Presented at the European Headache and Migraine Trust International
        Congress (EHMTIC), 4-7 September 2008; Abstract number 71.
    (2) Beck E, Sieber WJ, Trejo R. Management of cluster headaches. American
        Family Physician. 2005; 71(4).
    (3) Matharu MS, Goadsby PJ. Cluster headache: focus on emerging
        therapies. Expert Rev Neurother. 2004; 4(5):895-907.
    (4) Hedlund C, Rapoport A, Goadsby P. Zolmitriptan nasal spray in the
        acute treatment of cluster headache: a meta-analysis of two
        double-blind, placebo-controlled, randomized, cross-over studies.
        Presented at the European Headache and Migraine Trust International
        Congress (EHMTIC), 4-7 September 2008; Poster number PF.03.
    (5) Newman LC, Goadsby PJ, Lipton RB. Cluster and related headaches. Med
        Clin North Am. 2001; 85:997-1016.
    (6) Cluster Headache Help 2008. http://www.chhelp.org/. Last accessed May
        2008.
    (7) Bahra A, May A, Goadsby PJ. Cluster headache: a prospective clinical
        study with diagnostic implications. Neurology. 2002;58:354-61.
    (8) Headache Classification Subcommittee of the International Headache
        Society. The International Classification of Headache Disorders.
        2nd ed. Cephalalgia. 2004;24(suppl 1):9-160.
    (9) Rozen TD. Cluster headache: diagnosis and treatment. Curr Pain
        Headache Rep. 2005; 9(2):135-40.
    (10) Charlesworth BR, Dowson AJ, Purdy A et al. Speed of onset and
         efficacy of zolmitriptan nasal spray in the acute treatment
         of migraine: a randomised, double-blind, placebo-controlled,
         dose-ranging study versus zolmitriptan tablet. CNS Drugs.
         2003; 17(9):653-67.
    (11) MacGregor E, Brandes J, Eikermann A et al. Impact of migraine on
         patients and their families: the Migraine and Zolmitriptan 
         evaluation (MAZE) survey - Phase III. Curr Med Res Opin. 
         2004; 20(7):P1-P8.