DrugsAdvisoryCommit.ppt

July 13, 2005 PADAC Meeting Pulmonary-Allergy Drugs Advisory Committee MeetingJuly 13, 2005 Safety of Long-acting Beta-agonist Bronchodilators Salmeterol Sally M. Seymour, M.D. Medical Officer Division of Pulmonary and Allergy Drug Products Salmeterol Regulatory History Post-marketing Studies Serevent Nationwide Surveillance Study (SNS) Salmeterol Multicenter Asthma Research Trial (SMART) Post-marketing Spontaneous Reports Product Label Summary Salmeterol Regulatory History Post-marketing Studies Serevent Nationwide Surveillance Study (SNS) Salmeterol Multicenter Asthma Research Trial (SMART) Post-marketing Spontaneous Reports Product Label Summary Regulatory History Serevent Inhalation Aerosol Approved February 1994 for asthma Maintenance treatment of asthma prevention of bronchospasm in patients with reversible obstructive airways disease Discontinued by Sponsor as part of CFC phase out Serevent Diskus Approved September 1997 Advair Diskus Fluticasone propionate salmeterol xinafoate Approved August 2000 Regulatory History Salmeterol Inhalation Aerosol NDA Two Phase 3 twelve-week clinical trials (n=556) Improvement in FEV1 Improvement in AM PEFR Improvement in mean % days and mean % nights with no asthma symptoms Less rescue medication use SNS results considered Advisory committee February 1993 Approved February 1994 for asthma Regulatory History Reports of life-threatening respiratory events and fatalities within first 6 months after approval Label revised January 1995 – new WARNINGS Serious acute respiratory events, including fatalities have been reported with salmeterol Salmeterol not for acute symptoms Salmeterol not a substitute for inhaled corticosteroids Salmeterol should not be initiated in worsening or acutely deteriorating asthma Patients should have a short acting beta agonist for acute symptoms Regulatory History Physician and patient education program Sponsor committed to safety study Salmeterol Multicenter Asthma Research Tria