Treprostinil Technosphere (TreT) is a combination drug-device product comprised of a dry powder formulation of treprostinil Inhalation Powder (TreT) and a small, portable, dry powder inhaler.
BREEZE is a safety and tolerability study where patients with PAH on a stable dose of Tyvaso (6 to 12 breaths 4 times daily [QID]) will be evaluated after switching to a corresponding dose of TreT.
Patients will undergo:
- PK assessments,
- Safety assessments,
- 6-Minute Walk Test (6MWT),
- Questionnaires for satisfaction/preference for inhaled devices and patient-reported PAH symptoms and impact.
Following 3 weeks of treatment with TreT, patients will be offered the opportunity to participate in the Optional Extension Phase until the study terminates or the drug/device becomes commercially available.
MannKind’s Treprostinil Technosphere® (“TreT”) is an innovative technology that provides PH patients with an alternative form of inhaled treprostinil in a device that is convenient, compact, and easy to use. TreT is expected to reduce administration times and device maintenance.