BREEZE Study Design: This open-label clinical study evaluated patients with PAH (N=51) who were on a stable dose of TYVASO and were switched to a corresponding dose of TYVASO DPI.¹

Patients underwent safety and pharmacokinetic assessments and 6-minute walk tests, and also completed questionnaires about device preference and satisfaction.¹

49 of 51 patients (96%) elected to continue therapy with TYVASO DPI in an optional extension phase (OEP) with follow-up visits every 8 weeks.¹

Select patient background information

• Patients started TYVASO ≥3 months prior to the baseline visit and were on a stable regimen (no change in dose within 30 days of baseline visit) of TYVASO (6 to 12 breaths QID)¹
• 80% of patients were on dual background therapy in addition to TYVASO¹*
  • If receiving other approved background therapy, the patient was required to be on a stable dose with no additions or discontinuations for a minimum of 30 days¹
• 61% of patients were FC II at screening^1†
• FC IV patients were excluded from the study²
• Patients had a mean baseline 6MWD of 418.9 m (SD 109.4)¹
• Patients had a forced expiratory volume in 1 second (FEV₁) ≥60% and forced expiratory volume in 1 second/forced vital capacity (FEV₁/FVC) ratio ≥60% during the 6 months prior to enrollment¹

During the treatment phase of the BREEZE study, most commonly reported (≥4% of patients) AEs in patients previously stable on TYVASO were^1,3:

Discontinuation of TYVASO DPI due to an AE occurred in 2 (3.9%) patients.¹

Patient tolerability, as assessed by incidence of new adverse events following transition to TYVASO DPI, was consistent with the expected known safety profile of TYVASO.³

The maximum mean treprostinil concentration occurred rapidly for both TYVASO and TYVASO DPI in the low-, mid-, and high-dose groups: 32 mcg (6-7 breaths; n=2), 48 mcg (8-10 breaths; n=27), and 64 mcg (11-12 breaths; n=22).^1,2

11.5 m additional increase in 6MWD¹

For patients previously stable on TYVASO, TYVASO DPI demonstrated a significant improvement in 6MWD at week 3 compared with TYVASO treatment at baseline. Interim results of the OEP suggest that this improvement was sustained over 51 weeks.¹