Europe Approves Bronchodilator Oxis Turbohaler (Eformoterol) For Children Six Years and Older
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Europe Approves Bronchodilator Oxis Turbohaler (Eformoterol) For Children Six Years and Older

LONDON, ENGLAND -- April 30, 2002 -- New treatment option for exercise-induced asthma licensed in the UK AstraZeneca UK Ltd announced today that its long-acting bronchodilator Oxis® Turbohaler® (eformoterol) has received approval from the Medicines Control Agency (MCA) for use in prevention of exercise-induced asthma (EIA) in adults and children (six years and older).

Oxis Turbohaler can be taken before exercise or other physical activity. Due to its rapid onset of action a patient can feel the effect within minutes of inhalation(1). The long-lasting action of Oxis provides up to 12 hours protection(1) against symptoms of asthma such as shortness of breath, wheezing and chest tightness, all of which can be triggered by exertion. Eformoterol has been shown to provide significantly better protection against exercise-induced asthma for up to 12 hours compared to short-acting bronchodilators in children(2,3) and adults(4). In a trial in adult athletes, Oxis Turbohaler was shown to be effective in protecting against EIA as early as 15 minutes after inhalation(5).

Both strengths of Oxis Turbohaler (Oxis Turbohaler 6 and Oxis Turbohaler 12) have been licensed for this indication. For adults and children (aged six years and older) the dose is two actuations before exercise for Oxis 6 or one actuation of Oxis 12 (i.e.12 mg). The maximum daily dose given for normal dosage should not be exceeded. This maximum daily doses for Oxis 6 are 4 actuations for children (aged six years and older) and 8 actuations for adults(1). The maximum daily doses for Oxis 12 are 2 actuations for children (aged six years and older) and 4 actuations for adults(1). “Exercise-induced asthma is a problem often seen by healthcare professionals that can have a major impact on the lives of children and adults by limiting normal physical activities such as sport or walking up stairs.

The approval of Oxis Turbohaler for use in preventing exercise-induced asthma in patients over six years will provide a new and effective treatment option.” said Dr Paul Stephenson, a GP at Christmas Maltings Surgery, Haverhill, Suffolk. AstraZeneca 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 over $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.

In January 2002 Oxis received a licence for use in children (six years and over) for the maintenance treatment of asthma when treatment with corticosteroids is not sufficient.

The correct British Approved Name (BAN) of the active ingredient of Oxis Turbohaler is eformoterol not formoterol.

References
1. Oxis Turbohaler 6 SmPC and Oxis Turbohaler 12 SmPC.
2. Gronnerod TA, von Berg A, Schwabe G, et al. Formoterol via Turbuhaler® gave better protection than terbutaline against repeated exercise challenge for up to 12 hours in children and adolescents. Respir Med 2000; 94(7): 661-7.
3. Daugbjerg P, Nielsen KG, Skov M, et al. Duration of action of formoterol and salbutamol dry-powder inhalation in prevention of exercise-induced asthma in children. Acta Paediatr 1996; 85(6): 684-7.
4. Vilsvik J, Ankerts J, Palmqvist M, et al. Protection against cold air and exercise-induced bronchoconstriction while on regular treatment with Oxis. Respir Med 2001; 95(6): 484-90.
5. Ferrari M, Balestreri F, Baratieri S, et al. Evidence of the rapid protective effect of formoterol dry-powder inhalation against exercise-induced bronchoconstriction in athletes with asthma. Respiration 2000; 67(5): 510-3.

For further information please contact:
Jeremy Clark, Bryony Box or Katherine Riedtmann at Munro & Forster Communications
Tel: 020 7815 3900
Or
Edel McCaffrey at AstraZeneca UK Ltd.
Tel: 01582 836 475

SOURCE: AstraZeneca

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