United Therapeutics (NASDAQ:UTHR) recently announced data from an open-label phase 1 study of Tyvaso DPI (inhaled treprostinil) in Pulmonary Arterial Hypertension or PAH. The study met its primary endpoint of demonstrating safety and tolerability in patients with PAH transitioning from Tyvaso (treprostinil) inhalation solution. Also, a pharmacokinetic (PK) study in healthy volunteers demonstrated comparable treprostinil exposure between Tyvaso DPI and Tyvaso Inhalation Solution.
Currently approved Tyvaso is a nebulized formulation while Tyvaso DPI is a dry powder formulation and, if approved, will provide a more convenient method of administration. The company plans to submit an NDA in April 2021 with an indication to treat pulmonary arterial hypertension (PAH), as well as pulmonary hypertension associated with interstitial lung disease (PH-ILD) based on the INCREASE study. It will also use a priority review voucher for the NDA, which will reduce the approval period by 4 months.
Secondary objectives of the study were to evaluate: (1) the systemic exposure and pharmacokinetics of treprostinil when delivered as Tyvaso Inhalation Solution and Tyvaso DPI; (2) six-minute walk distance (6MWD) at study entry and after three weeks of treatment with Tyvaso DPI; (3) the long-term safety and tolerability of Tyvaso DPI during an optional extension phase (OEP) in patients previously treated with Tyvaso Inhalation Solution; (4) patient satisfaction with and preference for inhaled treprostinil devices assessed at study entry when patients were using Tyvaso Inhalation Solution and after three weeks using Tyvaso DPI; and (5) patient-reported PAH symptoms and impact (PAH-SYMPACT®) assessed at study entry when patients were using Tyvaso Inhalation Solution and after three weeks using Tyvaso DPI.
Currently, all 3 approved drug classes in PAH are vasodilators: prostacyclin, endothelin, and nitric oxide pathways. There's need for a new method of treatment because current SoC does not stop disease progression, and all patients continue to
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