Tyvaso DPI™ is a combination drug-device product comprised of a dry powder formulation of treprostinil Inhalation Powder and a small, portable, dry powder inhaler.
The Phase 3 BREEZE study evaluating the safety and pharmacokinetics of switching PAH patients from Tyvaso® to Tyvaso DPI™ and the pivotal pharmacokinetic studies comparing Tyvaso to Tyvaso DPI have both been completed. We plan to submit an NDA in the first half of 2021 seeking an indication for Tyvaso DPI that includes both PAH as well as PH-ILD.
Tyvaso DPI™ is an innovative technology that provides PH patients with an alternative form of inhaled treprostinil in a device that is convenient, compact, and easy to use. Tyvaso DPI is expected to reduce administration times and device maintenance.