Wixela Inhub: A Generic Equivalent Treatment Option for Patients with Asthma or COPD
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REVIEW
Wixela Inhub: A Generic Equivalent Treatment Option for Patients with Asthma or COPD James F. Donohue Richard Allan
. Douglas S. Burgoyne . Jonathan K. Ward .
. Arkady Koltun
. Andrew Cooper
Received: September 29, 2020 / Accepted: November 19, 2020 Ó The Author(s) 2020
ABSTRACT Purpose: The purpose of this review is to discuss the development of WixelaTM InhubTM, a generic equivalent of Advair DiskusÒ, a fixeddose 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. Summary: 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.
J. F. Donohue (&) University of North Carolina at Chapel Hill, Chapel Hill, NC, USA e-mail: [email protected] D. S. Burgoyne University of Utah College of Pharmacy, Salt Lake City, UT, USA J. K. Ward R. Allan A. Cooper Mylan Pharma UK Ltd., Sandwich, Kent, UK A. Koltun Mylan Inc., Canonsburg, PA, USA
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.
PLAIN LANGUAGE SUMMARY The WixelaTM InhubTM device has been developed as a generic equivalent of Advair DiskusÒ, and provides a combination treatment 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 information about the Inhub device and studies conducted to show how Inhub and Diskus are comparable products. Based on the similar results between the two devices, Inhub can be used as a treatment option for patients with asthma or COPD.
Keywords: Asthma; COPD; Dry powder inhaler; Fluticasone propionate; Salmeterol
Pulm Ther
Key Summary Points This review discusses WixelaTM InhubTM, a generic equivalent of Advair DiskusÒ, a fixed-dose combination of fluticasone propionate/salmeterol powder for oral inhalation for patients with asthma and chronic obstructive pulmonary disease (COPD). Wixela Inhub gave in vitro performance comparable to Advair Diskus for all strengths and flow rates for both single actuation content and impactor-sized mass. Compared with matched placebo, Wixela Inhub and Advair Diskus both demonstrated statistically significant improvements for forced expiratory volume in 1 s (FEV1). Fluticasone propionate/salmeterol dose strengths for Wixela Inhub and Advair Diskus are comparable. The bioequivalence demonstrated supports the use of Wixela Inhub and provides a treatment option for patients with asthma or COPD.
DIGITAL FEATURES This article is pu
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