United Therapeutics announced that its BREEZE study has demonstrated that patients with pulmonary arterial hypertension (PAH) who use Tyvaso treprostinil inhalation solution can safely switch to the Tyvaso treprostinil DPI. The company also announced that a PK study in healthy volunteers showed that the treprostinil exposure from Tyvaso DPI was comparable to that of Tyvaso inhalation solution. United Therapeutics recently announced that it was acquiring a priority review voucher to use with an NDA for Tyvaso DPI.
The BREEZE study enrolled 51 PAH patients who had been using Tyvaso inhalation solution and who were switched to a comparable dose of Tyvaso DPI for three weeks. After the initial three weeks, patients demonstrated improvements in 6-minute walk distance, patient reported outcomes, and patient satisfaction; and all 49 of the patients who completed the initial treatment phase chose to continue to use Tyvaso DPI in an optional extension phase.
The PK study in 36 healthy volunteers compared three dose levels of Tyvaso DPI to three corresponding dose levels of Tyvaso inhalation solution and found comparable treprostinil exposure for each of the three dose levels. In addition, the inter-subject variability for Tyvaso DPI was significantly lower than for Tyvaso inhalation solution for both AUC0-5h and Cmax.
United Therapeutics VP of Product Development Leigh Peterson commented, “We are pleased with these results, which demonstrate the safety, tolerability, and pharmacokinetic profiles of treprostinil administered as Tyvaso DPI. We look forward to submitting our new drug application for Tyvaso DPI in April. If approved, we expect Tyvaso DPI will provide a major advancement in the delivery of inhaled treprostinil therapy, offering convenience benefits compared to our existing Tyvaso nebulizer.”
Read the United Therapeutics press release.
