United Therapeutics wins FDA nod for third-gen Tyvaso TD-300/A nebulizer

United Therapeutics (NSDQ:UTHR) said today that its third-generation inhalation device designed for use with its Tyvaso treprostinil inhalation solution won FDA approval.

Tyvaso first won FDA approval in 2009 as a treatment for pulmonary arterial hypertension, the company said, with an ultrasonic nebulizer. United Therapeutics touted its drug-device combo as the most-prescribed inhalation therapy for PAD in the U.S.

The TD-300/A device, designed using patient and physician feedback, has a single button and an interface that helps patients get through the inhalation process, according to the company.

“We are extremely proud of this new device, which is just one example of our commitment to improving the ease of administration of treprostinil therapy so that more patients can benefit from our medicine,” chairman & CEO Martine Rothblatt said in prepared remarks.

“We are not resting on our laurels with this device, however. 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.”

“Tyvaso is an important element of our continuum of care, which provides a range of treprostinil therapy options across a spectrum of PAH patients,” president & COO Michael Benkowitz added. “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.”