Pharmacokinetic (PK) Bioequivalence And Comparable Efficacy/Safety Were Demonstrated With Pearl Therapeutics' Formoterol Fumarate MDI (FF-MDI, PT005) Compared To Foradil® Aerolizer® In A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study In Patients With Moderate To Very-Severe Chronic Obstructive Pulmonary Disease

Rose, Elizabeth L.; Strom, Shannon; Fischer, Tracy; Vasilinin, Grygoriy; Golden, Michael A.; Marier, Jean‐François; Reisner, Colin; Orevillo, Chad

doi:10.1164/ajrccm-conference.2012.185.1_meetingabstracts.a2927

Cited by 3 publications

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“…Studies of FF versus marketed Foradil 1 Aerolizer 1 (Merck, USA) administered twice-daily report comparable bioequivalence and efficacy in moderate-to-very-severe COPD patients [6,7]. This could provide an alternative device option for COPD patients who prefer MDIs.…”

Section: B 2 Agonistsmentioning

confidence: 99%

Emerging therapeutic strategies in COPD

Babu

Morjaria

2015

Drug Discovery Today

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Section: B 2 Agonistsmentioning

confidence: 99%

Emerging therapeutic strategies in COPD

Babu

Morjaria

2015

Drug Discovery Today

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GFF MDI for the improvement of lung function in COPD – A look at the PINNACLE-1 and PINNACLE-2 data and beyond

Rabe

2017

Expert Review of Clinical Pharmacology

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Chronic obstructive pulmonary disease (COPD) is the third leading cause of death globally and incidence rates are continuing to rise. Long-acting bronchodilators are the foundation on which current pharmacological approaches to COPD management are built, with long-acting muscarinic antagonists (LAMAs) and long-acting β-agonists (LABAs) recommended across the spectrum of the disease continuum. Combining LAMAs and LABAs provides additional lung function improvements and relief of patient symptoms compared with either therapy alone. Several options for LAMA/LABA fixed-dose combinations (FDC) delivered via a single inhaler device are available; however, only recently has a LAMA/LABA FDC become available as a pressurized metered dose inhaler (MDI). Areas covered: This article describes the rationale for the development of the LAMA/LABA FDC of glycopyrrolate and formoterol fumarate, formulated by Co-Suspension™ Delivery Technology and delivered by MDI (GFF MDI). The clinical trial program of GFF MDI, including the pivotal Phase III studies (PINNACLE-1 and PINNACLE-2) that supported regulatory approval, are reviewed, providing insights into interpretation and future directions for research. Expert commentary: LAMA/LABA FDCs are already a crucial part of the COPD treatment paradigm, but additional data are needed in order to maximize their role as maintenance therapies in patients with COPD.

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Pearl Therapeutics' Formoterol Fumarate MDI (FF-MDI, PT005) Demonstrates Pharmacokinetic Bioequivalence To Foradil® Aerolizer® In A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Crossover Phase 2b Study In Patients With Moderate To Severe Chronic Obstructive Pulmonary Disease

Orevillo¹,

Fogarty²,

Dunn³

et al. 2012

B41. Copd: Pharmacological Treatment

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Rationale:In developing an alternative formulation of formoterol fumarate (FF), systemic exposure from the new product must be similar to an approved formulation and maintain a similar pharmacodynamic (PD) response. In order to evaluate dose-response, and assure assay sensitivity, doses higher than the approved product should be administered to demonstrate superior PD response relative to the approved dose. Pearl has previously demonstrated bioequivalence between FF-MDI and Foradil® Aerolizer® (Foradil). Pearl conducted a single dose crossover study to compare FF-MDI to Foradil at the approved and higher doses. Methods: In a randomized, double-blind, six period, crossover study conducted in patients with moderate to severe COPD that were reversible to albuterol, 3 doses of FF-MDI (7.2, 9.6 and 19.2µg) were compared to placebo MDI, and Foradil (12 and 24 µg). Pharmacokinetic (PK) and PD assessments were conducted for 12 hours following each dose. The primary efficacy endpoint was FEV AUC relative to pre-dose 1 0-12 baseline at the start of each treatment day. Secondary endpoints included Peak FEV , morning trough FEV and safety assessments. Full 1 1 PK profiles were obtained throughout the 12â€'hour observation period. An ANOVA was used in the analyses of the ln-transformed PK parameters AUC , and C . The resulting mean estimates (Geometric Least-Squares Means, Geometric LSM) for each treatment were 0-12 max computed. Results: Fifty patients were randomized. All doses of FF-MDI and Foradil were superior to placebo for the primary endpoint (P<0.0001 for all comparisons). FF-MDI 7.2 µg and FF-MDI 9.6 µg were non-inferior to Foradil 12 µg. Foradil 24 µg was superior to Foradil 12 µg (mean difference = 52 mL) and FF-MDI 19.2 µg was superior to FF-MDI 9.6 µg (mean difference = 42 mL), demonstrating assay sensitivity across both formulations. Bioequivalence between FF-MDI 9.6 µg and Foradil 12 µg was demonstrated by the ratio of Geometric LSMs and 90% CI for AUC (0.98, 0.90-1.07, respectively), and for Cmax (0.96, 0.87-1.07, respectively). Similar PK results were observed for the 0-12 comparison between FF-MDI 19.2 µg and Foradil 24 µg. All products were safe and well tolerated with no substantial differences across formulations. Conclusion: This is the second study in which Pearl Therapeutics' formulation of FF-MDI 9.6 µg demonstrated bioequivalence and comparable efficacy and safety to Foradil® Aerolizer® 12 µg. In this study, assay sensitivity was achieved with comparable findings across the two higher doses.

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Cited by 3 publications

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Emerging therapeutic strategies in COPD

Emerging therapeutic strategies in COPD

GFF MDI for the improvement of lung function in COPD – A look at the PINNACLE-1 and PINNACLE-2 data and beyond

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