Thursday, July 13, 2006

New data reported on use of Symbicort for the maintenance and symptomological relief of asthma

Todays Headlines from across the DailyUpdates network
  • Featured Journal Article (from DailyUpdates-Immunology and Inflammatory Diseases): New data reported on use of Symbicort for the maintenance and symptomological relief of asthma There is a positive outlook for the respiratory market over the next five years, which will experience a sustained period of growth driven by the expansion of sales in existing classes, the launch of major new products, and the results from several landmark studies. Global asthma/COPD sales should grow to $23 billion by 2014, with inhaled corticosteroid/long-acting bronchodilator combinations set to be the leading class by value in 2014, followed by leukotriene antagonists, and anticholinergics (see our feature on Asthma and COPD). Today’s featured study published by Rabe and colleagues describes an AstraZeneca sponsored study of one of the leading combinations, budesonide/formoterol. This combination, marketed by AstraZeneca as Symbicort, provides the inhaled corticosteroid budesonide (Pulmicort) and the rapid and long-acting bronchodilator formoterol (Oxis) in a single dose adjustable inhaler (Turbuhaler). Symbicort is indicated for the maintenance treatment of asthma in adults and children aged 6 years and above and for the treatment of patients with severe COPD. Today’s featured study compares Symbicort with a higher dose of budesonide plus as-needed terbutaline, a beta-2 adrenoceptor agonist commonly used as a short-term asthma treatment. Patients were randomized to receive either Symbicort for maintenance and, crucially, additional inhalations as needed for symptom relief, or budesonide for maintenance medication plus terbutaline as needed. Use on an as needs basis was built into the study design to evaluate a new approach being developed by AstraZeneca known as SMART. Under these conditions Symbicort showed much greater improvements in morning peak expiratory flow and fewer exacerbations or hospital treatments than patients receiving budesonide; these improvements were achieved with a reduction in total steroid load. Currently Symbicort is approved as a maintenance treatment of asthma in 93 countries following initial approval in Sweden in 2000. Of note FDA approval has yet to be granted although an NDA was filed in 2005. Although US market entry has not yet occurred, annual sales are now in excess of $1 billion, largely due to European success. 2005 saw the publication of two papers supporting the use of Symbicort as a SMART therapy. STAY established improved efficacy using this approach as compared to fixed dosing; COSMOS demonstrated greater efficacy as compared to fixed dose fluticasone/salmeterol (the primary competitor to Symbicort marketed by GSK as Advair). Today’s featured study provides further support ot the SMART approach, regulatory approval for which was filed in 2005. Approval of the SMART approach plus FDA approval should lift sales of Symbicort way past even current figures. [Chest. 2006 Feb;129(2):246-56]


Post a Comment

<< Home