BREEZE STUDY

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.²

Patients underwent safety and pharmacokinetic assessments and 6-minute walk tests and also completed questionnaires about device preference and satisfaction.²

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.²

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)²
• 80% of patients were on dual background therapy in addition to TYVASO²*
  • 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 days²
• 61% of patients were FC II at screening^2†
• FC IV patients were excluded from the study³
• Patients had a mean baseline 6MWD of 418.9 m (SD 109.4)²
• 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 enrollment²

Results

Adverse reactions: Consistent safety and tolerability when switching to TYVASO DPI³

During the 3-week treatment phase of the BREEZE study, most commonly reported (≥4% of patients) AEs in patients previously stable on TYVASO were^2,3:

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

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

AE rate declined during the OEP, suggesting that TYVASO DPI tolerance may improve over time.^2,3

Systemic exposure was similar between TYVASO DPI and TYVASO^1,2

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).²

11.5 m additional increase in 6MWD²

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.²

Satisfaction with TYVASO DPI significantly improved when compared with TYVASO²

45/46 (P<0.0001)

REPORTED PATIENT SATISFACTION WITH TYVASO DPI

REPORTED PATIENT SATISFACTION WITH TYVASO DPI

at week 3 compared with 31% (16/51) of patients satisfied with the TYVASO ultrasonic nebulizer at baseline.²