Posted by Michael Wonder on 28 Jan 2020
Liquidia submits new drug application for LIQ861 (treprostinil) inhalation powder to U.S. FDA for the treatment of pulmonary arterial hypertension
27 January 2020 - Liquidia Technologies today announced the submission of its New Drug Application (NDA) to the U.S. FDA for LIQ861.
LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed using Liquidia’s PRINT® technology with the goal of enhancing deep-lung delivery using a convenient, palm-sized dry powder inhaler for the treatment of pulmonary arterial hypertension (PAH).
The NDA has been submitted under the 505(b)(2) regulatory pathway and includes data from three clinical studies to establish the safety, tolerability and pharmacokinetic profile of LIQ861. The open-label Phase 3 study, known as INSPIRE (Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil) (NCT03399604), included 121 PAH patients who transitioned from stable doses of the reference listed drug or added LIQ861 to no more than two approved non-prostacyclin oral PAH therapies. The company also completed pharmacokinetic studies to establish the bioavailability of LIQ861 relative to the bioavailability of the reference listed drug.
