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| |  FDA Approves QVAR (Beclomethasone Dipropionate HFA) Inhalation Aerosol For The Treatment Of Asthma ST. PAUL, MN -- September 18, 2000 -- 3M Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval for QVAR™ (beclomethasone dipropionate HFA) Inhalation Aerosol for the treatment of asthma. QVAR, a unique aerosol metered dose inhaler (MDI) which contains beclomethasone dipropionate (BDP) in a solution and no chlorofluorocarbon (CFC) propellant, is the first inhaler designed to deliver smaller-particle-sized medication to the large, intermediate and small airways. This allows QVAR to control asthma at a lower dose than conventional CFC-containing BDP inhalers. New QVAR is indicated for the preventive management of asthma for people over the age of 12 and contains the safe and effective corticosteroid, beclomethasone dipropionate. "Both the large and small airways in the lungs play an important role in asthma, but current inhalers fail to deliver medication to the smallest airways. This new drug represents a potential breakthrough for patients with asthma," said Sally Wenzel, M.D., a leading Pulmonologist from the National Jewish Medical and Research Center in Denver, Colorado. The efficacy of inhaled corticosteroids for the treatment of asthma is well established, both nationally and internationally, with treatment guidelines recommending their use as first-line therapy.(1-7) Corticosteroids, such as QVAR, for the treatment of asthma are usually administered by inhalation through a metered dose inhaler. Recent studies have shown that, in contrast to CFC-beclomethasone dipropionate (CFC-BDP) inhalers, QVAR delivers more medication to the lungs, where it is needed, and deposits less in the throat.(4) With QVAR, approximately 50 percent of the drug is administered to the lungs. Clinical trials have shown QVAR to be effective to conventional BDP at a lower dose.(1,2,8,9) At recommended doses, QVAR was not associated with any clinically relevant systemic side effects in adults.(9) QVAR is the first CFC-free metered dose inhaler containing a corticosteroid. QVAR is a formulation of the anti-inflammatory drug BDP, which uses the ozone friendly propellant hydrofluoroalkane (HFA). All CFC-containing inhalers will eventually be phased out in the United States. Thus, QVAR is a CFC-free BDP that has been developed to meet this change. References: 2. Demedts M, et al. Switch to non-CFC inhaled corticosteroids: a comparative efficacy study of HFA-BDP and CFC-BDP metered-dose inhalers. Int J Clin Pract. 1999;53:331-338. 3. Goldin JG, et al. Comparative effects of hydrofluoroalkane and chlorofluorocarbon beclomethasone dipropionate inhalation on small airways: assessment with functional helical thin-section computed tomography. J Allergy Clin Immunol. 1999;104:S258-S267. 4. Leach CL, et al. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998;12:1346-1353. 5. Hamid Q, et al. Respiratory pathophysiologic responses. Inflammation of small airways in asthma. J Allergy Clin Immunol. 1997;100:44-51. 6. Martin RJ. Small airway and alveolar tissue changes in nocturnal asthma. Am J Resp Crit Care Med. 1998;157:S188-S190. 7. Macklem PT. The physiology of small airways. Am J Resp Crit Care Med. 1998;157:S181-S183. 8. Matthys H, et al. Efficacy of chlorofluorocarbon-free beclomethasone dipropionate 400 mcg day-1 delivered as an extrafine aerosol in adults with moderate asthma. Respir Med. 1998;92(suppl A):17-22. 9. Gross G, et al. Hydrofluoroalkane-134a beclomethasone dipropionate, 400 mcg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 mcg, for the treatment of moderate asthma. CHEST. 1999;115:343-351.
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