Robert F Roscigno1, Toby Vaughn2, Ed Parsley3, Thomas Hunt4, Michael A Eldon5, Lewis J Rubin6. 1. Clinical Development Consultant, Melbourne Beach, FL, USA. 2. Clinical Development Consultant, Rolesville, NC, USA. 3. Medical Monitor Consultant, San Diego, CA, USA. Electronic address: eparsley@att.net. 4. PPD Development, LLC, Austin, TX, USA. 5. Clinical Pharmacology Consultant, San Francisco, CA, USA. 6. Columbia University College of Physicians and Surgeons, New York, NY, USA.
Abstract
INTRODUCTION: Treprostinil is a synthetic prostacyclin analogue approved for inhalation administration to patients with pulmonary arterial hypertension (PAH) via nebulized Tyvaso® inhalation solution. LIQ861 is an inhaled, dry-powder formulation of treprostinil produced using Print® (Particle Replication in Nonwetting Templates) technology, a proprietary process for designing and producing highly uniform drug particles. METHODS: We conducted comparative bioavailability analyses of treprostinil exposure from LIQ861 (79.5 μg capsule [approximate delivered dose of 58.1 μg treprostinil]) compared with Tyvaso® (9 breaths [approximate delivered dose of 54 μg treprostinil]). RESULTS: Treprostinil exposure parameters had least squares geometric mean ratios (LIQ861: Tyvaso®) between 0.9 and 1.0 with 90% confidence intervals contained within 0.8 to 1.25. LIQ861 and Tyvaso® were both well tolerated. DISCUSSION: Results showed comparable bioavailability of treprostinil and similar tolerability for LIQ861 and Tyvaso® administered to healthy adults. CONCLUSIONS: Given the comparable treprostinil bioavailability and similar safety profiles of LIQ861 and Tyvaso®, LIQ861 fulfills a significant unmet need for PAH patients by maximizing the therapeutic benefits of treprostinil by safely delivering doses to the lungs in 1 to 2 breaths using a discreet, convenient, easy-to-use inhaler.
INTRODUCTION:Treprostinil is a synthetic prostacyclin analogue approved for inhalation administration to patients with pulmonary arterial hypertension (PAH) via nebulized Tyvaso® inhalation solution. LIQ861 is an inhaled, dry-powder formulation of treprostinil produced using Print® (Particle Replication in Nonwetting Templates) technology, a proprietary process for designing and producing highly uniform drug particles. METHODS: We conducted comparative bioavailability analyses of treprostinil exposure from LIQ861 (79.5 μg capsule [approximate delivered dose of 58.1 μg treprostinil]) compared with Tyvaso® (9 breaths [approximate delivered dose of 54 μg treprostinil]). RESULTS:Treprostinil exposure parameters had least squares geometric mean ratios (LIQ861: Tyvaso®) between 0.9 and 1.0 with 90% confidence intervals contained within 0.8 to 1.25. LIQ861 and Tyvaso® were both well tolerated. DISCUSSION: Results showed comparable bioavailability of treprostinil and similar tolerability for LIQ861 and Tyvaso® administered to healthy adults. CONCLUSIONS: Given the comparable treprostinil bioavailability and similar safety profiles of LIQ861 and Tyvaso®, LIQ861 fulfills a significant unmet need for PAH patients by maximizing the therapeutic benefits of treprostinil by safely delivering doses to the lungs in 1 to 2 breaths using a discreet, convenient, easy-to-use inhaler.
Authors: Adam J Plaunt; Tam L Nguyen; Michel R Corboz; Vladimir S Malinin; David C Cipolla Journal: Pharmaceutics Date: 2022-01-27 Impact factor: 6.321
Authors: Nicholas S Hill; Jeremy P Feldman; Sandeep Sahay; Raymond L Benza; Ioana R Preston; David Badesch; Robert P Frantz; Savan Patel; Ashley Galloway; Todd M Bull Journal: Pulm Circ Date: 2022-07-01 Impact factor: 2.886