Tyvaso DPI™, a next-generation dry powder formulation of treprostinil, is safe and well tolerated in patients with pulmonary arterial hypertension (PAH) who are currently using Tyvaso® inhalation solution, according to clinical data from a trial called BREEZE.
The data, presented at the European Respiratory Society (ERS) International Congress 2021, also showed that the transition to Tyvaso DPI led to significant improvements in 6-minute walk distance, device preference and satisfaction, and patient-reported outcomes.
“We are thrilled to share the BREEZE study data demonstrating the safety and tolerability of treprostinil administered as Tyvaso DPI, which, if approved by the FDA, could represent a more convenient formulation of inhaled treprostinil,” Peter Smith, PharmD, vice president, product development at United Therapeutics, said in a press release.
Tyvaso DPI is currently under review by the US Food and Drug Administration (FDA). It is comprised of a dry powder formulation of treprostinil and a portable dry powder inhaler.
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BREEZE is a phase 1b clinical trial evaluating the safety and tolerability of Tyvaso DPI in patients with PAH who are currently using Tyvaso. The primary outcome measure of the trial is the number of patients with treatment-emergent adverse events. The secondary outcome measures include changes in the 6-minute walk distance from baseline to week 3, patient satisfaction with and preference for inhaled treprostinil devices, and patient-reported PAH symptoms and the impact of the treatment.
The trial recruited 51 patients aged at least 18 years with PAH across the United States who had started Tyvaso more than 3 months prior to the beginning of the trial. It is currently active but no longer recruiting participants. It is expected to be completed in March 2022.
Leslie Spikes, MD, associate professor of pulmonary and critical care medicine at the University of Kansas Medical Center in Kansas City, stated, “The results of the study, even when taken into the context of the unblinded study design, indicate that Tyvaso DPI is a convenient, tolerable treprostinil formulation that could increase prostacyclin accessibility, with the potential to improve patient outcomes.”
United Therapeutics presents Tyvaso DPI™ BREEZE clinical data at the European Respiratory Society International Congress 2021. News release. United Therapeutics Corporation; September 07, 2021.
Open-label, clinical study to evaluate the safety and tolerability of TreT in subjects with PAH currently using Tyvaso (BREEZE). ClinicalTrials.gov. May 15, 2019. Updated March 30, 2021. Accessed September 8, 2021.