FDA Approves Third Generation Nebulizer for Tyvaso Inhalation System

Remodulin UT [United The.utics] FDA Gentiva.

Remodulin UT [United The.utics] FDA Gentiva.

The U.S. Food and Drug Administration (FDA) has approved a new, third-generation inhalation device, the TD-300/A, for use with Tyvaso (treprostinil) Inhalation SolutionUnited Therapeutics Corporation announced.

Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability.

Tyvaso was approved by the FDA for the treatment of PAH in 2009, as a new drug-device combination product. This included Tyvaso plus an ultrasonic nebulizer and accessories – referred to as the Tyvaso Inhalation System.

Since its launch, United Therapeutics has worked to improve patient compliance and enhance Tyvaso’s easiness of use. The TD-300/A is a product of that continuous investment. It was designed based on patient and physician feedback and now includes a cleaner, more ergonomic design, single button operations, an intuitive user interface that allows adjusting breath counts, and a graphical display that helps patients follow the inhalation process through time. The new device also allows patients to keep track of their last treatment and comes with an internal, rechargeable battery.

“Tyvaso is an important element of our continuum of care, which provides a range of treprostinil therapy options across a spectrum of PAH patients,” said Michael Benkowitz, president and chief operating officer of United Therapeutics in a press release. “The launch of the TD-300/A, planned for mid-2018, will further optimize Tyvaso therapy for patients and, we believe, reduce the rate of therapy discontinuation associated with the current nebulizer.”

Martine Rothblatt, PhD, chairman and CEO of United Therapeutics, shared the company’s plans: “We recently launched a new program to develop a small, metered dose inhalation device for treprostinil, and are planning to study the administration of inhaled treprostinil on a pro re nata ‘as needed’ basis, to provide more flexibility for patients to use inhaled treprostinil where they need it, when they need it. And of course, we are continuing the development of our advanced delivery devices for Remodulin, such as our RemUnity subcutaneous pump, and RemoPro, a prodrug formulation of treprostinil,” she said.

In a previous study, researchers found that Tyvaso was well-tolerated and safe in routine clinical use. The study, “An observational study of inhaled-treprostinil respiratory-related safety in patients with pulmonary arterial hypertension,” was published in the Pulmonary Circulation.

The findings were taken from a long-term prospective and observational safety clinical trial (NCT01266265), which enrolled 1,333 patients from 94 centers throughout the U.S.

This study found that within the group of patients treated with inhaled Tyvaso, 403 patients (61 percent) registered 1,281 respiratory-related adverse effects. From the control group, 388 patients (58 percent) reported 1,295 respiratory-related negative effects.

The most common adverse reactions included cough, throat irritation, nasal discomfort, and hemoptysis (coughing up of blood). Those events occurred at higher numbers per patient-year of exposure in the inhaled Tyvaso group than in the control group.

The overall results showed that inhaled Tyvaso was well-tolerated by PAH patients in routine clinical care with less than 1 percent of patients discontinuing treatment due to adverse effects.

Tyvaso is currently the most-prescribed inhalation therapy for PAH in the U.S.

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