XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol provides rapid relief with a strong response for your pediatric patients*2,3

*Based on data averaged over 4 weeks.
A multicenter, randomized, double-blind, parallel-group, 4-week trial of pediatric patients (N=150). Patients were randomized to receive XOPENEX HFA 90 mcg, albuterol HFA 180 mcg, or placebo. The primary endpoint was peak percent change in FEV1 from visit predose averaged over the double-blind period.2

  • 34% of pediatric patients treated with XOPENEX HFA® (levalbuterol tartrate) achieved an average peak increase in FEV1 of ≥30% (24% with albuterol HFA; 15% with placebo)*2
  • Significant improvement in peak percent change in FEV1 from visit predose averaged over the double-blind period (primary endpoint) vs placebo (P<0.001)2
  • None of the patients in the XOPENEX HFA group, 15.8% of patients in the albuterol HFA group, and 30.3% of patients in the placebo group had an average peak increase in FEV1 of <10%*2

XOPENEX and other β-agonists can cause paradoxical bronchospasm, which may be life threatening.

Onset was defined as the postdose time point at which a response of ≥ 15% FEV1 first occurred. The time of onset was calculated by linear interpolation between the last time point of nonresponse and the first time point of response. The median time to achieve FEV1 response ≥15% after the first dose was 4.5 minutes for XOPENEX HFA 90 mcg and 4.9 minutes for albuterol HFA 180 mcg at Week 0; and 40.1 minutes for XOPENEX HFA 90 mcg and 102.1 minutes for albuterol HFA180 mcg at Week 4.

  • Median onset of response for XOPENEX HFA was 4.5 minutes; 4.9 minutes for patients taking albuterol HFA; and 272 minutes for patients taking placebo1,3
  • Albuterol HFA was included as an active comparator to validate the overall study design.2 The study was not designed for comparison of XOPENEX HFA to albuterol HFA

Due to the cardiovascular side effects associated with β-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), diabetes, hyperthyroidism, or convulsive disorders.

References:
1. XOPENEX HFA Inhalation Aerosol [prescribing information]. Marlborough, MA: Sepracor Inc; June 2009.

2. Berger WE, Milgrom H, Skoner DP, Tripp K, Parsey MV, Baumgartner RA; for the Xopenex Pediatric Asthma Group. Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial. Curr Med Res Opin. 2006;22(6):1217-1226.

3. Data on file, CSR051-354. Sunovion Pharmaceuticals Inc.

 

 
 

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