Tyvaso DPI: Drug-device characteristics and patient clinical considerations.

Tyvaso DPI is a drug-device combination therapy comprised of a small, portable, reusable, breath-powered, dry powder inhaler (DPI) for the delivery of treprostinil. It is approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Tyvaso DPI utilizes single-use prefilled cartridges to ensure proper dosing. Unlike nebulizer devices, administration of Tyvaso DPI is passive and does not require coordination with the device. The low-flow rate design results in targeted delivery to the peripheral lungs due to minimal drug loss from impaction in the oropharynx. The inert fumaryl diketopiperazine (FDKP) excipient forms microparticles that carry treprostinil into the airways, with a high fraction of the particles in the respirable range. In a clinical study in patients with pulmonary arterial hypertension, Tyvaso DPI had similar exposure and pharmacokinetics, low incidence of adverse events, and high patient satisfaction compared with nebulized treprostinil solution. Tyvaso DPI may be considered as a first prostacyclin agent or for those that do not tolerate other prostacyclin formulations, patients with pulmonary comorbidities, patients with mixed Group 1 and Group 3 pulmonary hypertension, or those that prefer an active lifestyle and need a portable, non-invasive treatment. Tyvaso DPI is a patient-preferred, maintenance-free, safe delivery option that may improve patient compliance and adherence.

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Déclaration de conflit d'intérêts

Declaration of competing interest CM has received payment or honoraria from United Therapeutics and has participated on a data safety monitoring board or advisory board, for United Therapeutics, Merck, and Janssen Pharmaceuticals. RA is a member of an advisory board, has done disease state specific speaking engagements, and participates in clinical trials sponsored by United Therapeutics. SSa has received payments for speaking (promotional/non-promotional), consulting, and research from United Therapeutics, Liquidia Technologies, Gossamer Bio, Bayer, GlaxoSmithKline, and Janssen/Johnson and Johnson. CME has received payment or honoraria from United Therapeutics and has served on Advisory Boards for United Therapeutics. SSh is involved in research projects with United Therapeutics, Liquidia, Pharmousa, and Gossamer but receives no compensation for this work. CS is an employee of MannKind. CD, TW, BND, and MB are employees of United Therapeutics. CB has participated in multi-center interventional trials sponsored by United Therapeutics and is a consultant for INSMED, Gossamer Bio, and Janssen.