United Therapeutics Gets FDA Clearance to Start Phase 2 Trial of Treprostinil Soft Mist Inhaler

MT Newswires Live10-19

United Therapeutics (UTHR) said Monday the US Food and Drug Administration cleared its phase 2 trial of an investigational soft mist inhaler version of treprostinil in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease.

The 16-week double-blind study will track safety and tolerability in about 40 patients, with secondary endpoints covering exercise capacity and a heart failure marker, the company said.

If the trial succeeds, a phase 3 registration study is planned for 2028, United Therapeutics said.

The product includes a handheld device that delivers treprostinil in a single breath and can be stored at room temperature, the company said.

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