SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 15, 2020 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced it will present clinical trial data on Tyvaso® (treprostinil) Inhalation Solution in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) at CHEST 2020, the annual meeting of the American College of Chest Physicians, which will be held on October 18-21. The presentation will include data from the phase 3 INCREASE study of Tyvaso in patients with PH-ILD, which included an evaluation of the impact of Tyvaso on parameters on lung function measured by patients' forced vital capacity. Additionally, data will be presented on the Orenitram® ADAPT registry, the utilization of parenteral prostacyclin therapy prior to death among Medicare patients with pulmonary arterial hypertension (PAH), and the psychological impact of living with PAH.

"We look forward to presenting important new data on the potential impact of Tyvaso on lung disease in PH-ILD patients, as well as research related to the treatment of PAH, at CHEST 2020," said Gil Golden, M.D., Ph.D., Chief Medical Officer of United Therapeutics. "We are not only committed to evaluating our prostacyclin therapies, but also to addressing existing scientific gaps with the aim of providing healthcare professionals with new data that can help inform treatment decisions." 

Details of the poster presentations at CHEST 2020 are as follows:

Title: The Impact of Inhaled Treprostinil on Patient Lung Function: Results from the INCREASE Study Lead Author: Aaron Waxman

Title: Interim Data from the ADAPT Registry: Patient-Reported Real-World Tolerability and Management of Adverse Events with Oral Treprostinil Lead Author: John Kingrey

Title: Reasons for Refusing Parenteral Therapy: A Qualitative Study of Patients with Pulmonary Arterial Hypertension Lead Author: Kellie Morland

Title: Contemporary Dosing Characteristics of Oral Treprostinil in Real-world Clinical Practice in Patients with Pulmonary Arterial Hypertension Lead Author: Karim El-Kersh

Title: Development of the Pulmonary Hypertension Functional Classification Self-Report (PH-FC-SR)Lead Author: Kristin Highland 

Title: Low Utilization of Prostacyclin Therapy Prior to Death Among Medicare Patients with Pulmonary Arterial Hypertension Lead Author: Stephen Mathai

Title: Understanding the Psychological Mindset of People with Pulmonary Arterial Hypertension Lead Author: Lillian Hansen

The e-posters will be available on the CHEST 2020 website (click here).

About TYVASO® (treprostinil) Inhalation Solution

INDICATION TYVASO (treprostinil) is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).

The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.

While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration.

IMPORTANT SAFETY INFORMATION FOR TYVASO

WARNINGS AND PRECAUTIONS

• The efficacy of TYVASO has not been established in patients with significant underlying lung disease (such as asthma or chronic obstructive pulmonary disease). Patients with acute pulmonary infections should be carefully monitored to detect any worsening of lung disease and loss of drug effect
• TYVASO is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may cause symptomatic hypotension
• Titrate slowly in patients with hepatic or renal insufficiency, as exposure to treprostinil may be increased in these patients
• TYVASO inhibits platelet aggregation and increases the risk of bleeding
• Co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor gemfibrozil may increase exposure to treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events, whereas decreased exposure is likely to reduce clinical effectiveness

DRUG INTERACTIONS/SPECIFIC POPULATIONS

• The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension
• Co-administration of the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to oral treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin decreases exposure to oral treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8
• Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production
• Safety and effectiveness in pediatric patients have not been established
• It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients

ADVERSE REACTIONS

• The most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs