James F Donohue1, Douglas S Burgoyne2, Jonathan K Ward3, Richard Allan3, Arkady Koltun4, Andrew Cooper3. 1. University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. james_donohue@med.unc.edu. 2. University of Utah College of Pharmacy, Salt Lake City, UT, USA. 3. Mylan Pharma UK Ltd., Sandwich, Kent, UK. 4. Mylan Inc., Canonsburg, PA, USA.
Abstract
PURPOSE: The purpose of this review is to discuss the development of Wixela™ Inhub™, a generic equivalent of Advair Diskus®, a fixed-dose combination of fluticasone propionate/salmeterol powder for oral inhalation for patients with asthma whose symptoms are not controlled with inhaled corticosteroids alone and for those with chronic obstructive pulmonary disease (COPD) who are at a high risk for exacerbations. We provide an overview of the Inhub device and the bioequivalence studies that have been conducted to date. Briefly, the in vitro performance, improvements in forced expiratory volume in 1 s, and the fluticasone propionate/salmeterol dose strengths for Wixela Inhub and Advair Diskus were comparable. CONCLUSION: The bioequivalence demonstrated by the totality of clinical and in vitro data supports the use of Wixela Inhub and provides a treatment option for patients with asthma or COPD.
PURPOSE: The purpose of this review is to discuss the development of Wixela™ Inhub™, a generic equivalent of Advair Diskus®, a fixed-dose combination of fluticasone propionate/salmeterol powder for oral inhalation for patients with asthma whose symptoms are not controlled with inhaled corticosteroids alone and for those with chronic obstructive pulmonary disease (COPD) who are at a high risk for exacerbations. We provide an overview of the Inhub device and the bioequivalence studies that have been conducted to date. Briefly, the in vitro performance, improvements in forced expiratory volume in 1 s, and the fluticasone propionate/salmeterol dose strengths for Wixela Inhub and Advair Diskus were comparable. CONCLUSION: The bioequivalence demonstrated by the totality of clinical and in vitro data supports the use of Wixela Inhub and provides a treatment option for patients with asthma or COPD.
Authors: Richard Allan; Kelly Canham; Roisin Wallace; Dave Singh; Jon Ward; Andrew Cooper; Claire Newcomb Journal: J Aerosol Med Pulm Drug Deliv Date: 2020-08-31 Impact factor: 2.849
Authors: Sarah E Ray; Vanessa Boudewyns; Christine Davis; Janice P Tzeng; Ila Srivastava; Oluwamurewa Oguntimein; Denise S Conti; Karen B Feibus Journal: Int J Chron Obstruct Pulmon Dis Date: 2022-08-06