Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®
The purpose of this multi-center, open-label, safety and tolerability study was to assess the
 addition of oral treprostinil (UT-15C sustained release [SR] tablets) to subjects currently
 receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period,
 the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk
 test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World
 Health Organization (WHO) Functional Class, and safety assessments.

 Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were
 receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies
 (endothelin receptor antagonists [ERAs] and/or phosphodiesterase type 5 inhibitor [PDE5-I],
 if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg
 UT-15C SR.
Significant inclusion criteria includes:

 1. Subjects were between 18 to 75 years of age

 2. Diagnosis of PAH: Idiopathic; Heritable; Associated with: Collagen vascular disease,
 Human immunodeficiency virus (HIV) infection, appetite suppressant or toxin use, or
 repaired congenital systemic-to-pulmonary shunts (repaired ≥5 years)

 3. Had been receiving Tyvaso for at least 4 weeks (≥9 breaths, 4 times a day [QID]) and
 required additional therapy

 4. In addition to Tyvaso, subjects may have been receiving other approved PAH specific
 oral therapies (ERAs and/or PDE-5 inhibitors, if at a stable dose).