United Therapeutics to Present Tyvaso DPI™ BREEZE Clinical Data at the European Respiratory Society International Congress 2021
Data from the BREEZE study of Tyvaso DPI, a dry powder inhaled formulation of treprostinil, will be presented in a poster session on
The primary objective of the study was to evaluate the safety and tolerability of Tyvaso DPI during a three-week treatment phase in PAH patients previously treated with Tyvaso Inhalation Solution. Top line data showing the BREEZE study met its primary objective were released in
Secondary objectives highlighted at the congress will include: (1) change in six-minute walk distance (6MWD); (2) patient satisfaction with and preference for inhaled treprostinil devices; and (3) patient-reported PAH symptoms and impact (PAH-SYMPACT®). Each objective was assessed at study entry when patients were using Tyvaso Inhalation Solution and after three weeks using Tyvaso DPI.
Additional pharmacokinetic (PK) data from the BREEZE and healthy volunteer studies will be presented at future medical congresses.
"We look forward to presenting important new data that serve as the basis of our pending New Drug Application for Tyvaso DPI," said
Details for the poster presentation at ERS 2021 are as follows:
BREEZE: Open-label, Clinical Study to Evaluate the Safety and Tolerability of a Treprostinil Dry Powder inhaler in Patients with Pulmonary Arterial Hypertension Currently using Tyvaso
The poster will be available on the United Therapeutics Pipeline website following the conclusion of the congress.
Also known as
About Tyvaso DPI
Tyvaso DPI™ is an investigational drug-device combination therapy comprised of a dry powder formulation of treprostinil and a small, portable, dry powder inhaler. If approved, Tyvaso DPI is expected to provide a more convenient method of administration compared with traditional nebulized Tyvaso® therapy.
About TYVASO® (treprostinil) Inhalation Solution
TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of:
- Pulmonary arterial hypertension (PAH;
WHO Group1) to improve exercise ability. Studies establishing effectiveness predominately included 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.
- Pulmonary hypertension associated with interstitial lung disease (PH-ILD;
WHO Group3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group3 connective tissue disease (22%).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- TYVASO is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension.
- TYVASO inhibits platelet aggregation and increases the risk of bleeding.
- Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, 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.
- Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to 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.
- Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH–ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.
Pulmonary Arterial Hypertension (
In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (
WHO Group1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea.
Pulmonary Hypertension Associated with ILD (
In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (
WHO Group3), adverse reactions were similar to the experience in studies of PAH.
Please see Full Prescribing Information, the TD-100 and TD-300 TYVASO® Inhalation System Instructions for Use manuals, and other additional information at www.tyvaso.com or call 1–877–UNITHER (1-877-864-8437).
Through our wholly owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company.
Please visit unither.com to learn more.
Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements relating to our planned presentations regarding Tyvaso DPI clinical data, our pending NDA for Tyvaso DPI, and the potential clinical benefits of Tyvaso DPI if and when it is approved by the FDA, our ability to create value and sustain our success in the long-term, as well as our efforts to develop technologies that either delay the need for transplantable organs or expand the supply of transplantable organs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the
TYVASO is a registered trademark of
TYVASO DPI is a trademark of
AFREZZA, BLUHALE, and DREAMBOAT are registered trademarks of
PAH-SYMPACT is a registered trademark of
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