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news.Aradigm has initiated a bridging clinical trial of inhaled treprostinil utilizing its AERx Essence pulmonary delivery system.
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The trial in healthy volunteers is being conducted in the UK to evaluate aerosol delivery by assessing lung distribution, pharmacokinetics and safety of inhaled treprostinil delivered by the AERx Essence system versus delivery with the Nebu-Tec Optineb-ir nebulizer. The Nebu-Tec device was used by Lung Rx, a wholly owned subsidiary of United Therapeutics, in the recently concluded Triumph study of inhaled treprostinil in patients with pulmonary arterial hypertension.
The company has received authorization to proceed with the clinical trial from the UK Medicinal Health Care products Regulatory Agency as required under the EU clinical trials directive.
Martine Rothblatt, chairman and CEO of Lung Rx and United Therapeutics, said: “We are delighted that we are making good progress with Aradigm towards providing PAH patients with ever more convenient ways to treat their condition using the palm-sized AERx Essence inhaler.”