The FDA has approved an updated nebulizer for use with United Therapeutics’ Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension, the company said. The new TD-300/A device will be launched next year.
According to United Therapeutics, the TD-300/A nebulizer “has a cleaner, more ergonomic design that includes single button operation, an intuitive user interface for adjusting breath counts, a color, graphical display that leads patients through the inhalation process and displays time since last treatment, and an internal, rechargeable battery.”
United Therapeutics Chairman and CEO Martine Rothblatt commented, “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. 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.”
President and Chief Operating Officer Michael Benkowitz added, “Tyvaso is an important element of our continuum of care, which provides a range of treprostinil therapy options across a spectrum of PAH patients. 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.”
Read the United Therapeutics press release.
