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.
In October 2021, we received a complete response letter from the FDA. The NDA is planned to be resubmitted addressing the single deficiency identified by the FDA.
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.