The FDA Clears United Therapeutics' Investigational New Drug Application To Proceed With SUMMIT Trial Of Treprostinil Soft Mist Inhaler In Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease

United Therapeutics Corporation (Nasdaq: UTHR) has received FDA clearance to proceed with the SUMMIT clinical trial of its investigational drug, treprostinil soft mist inhaler (SMI), for treating pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). The phase 2 study will involve approximately 40 patients and assess the drug's safety, tolerability, and efficacy. If successful, United Therapeutics plans to initiate a phase 3 registration study in 2028, with potential for significant market expansion, as PH-COPD could affect five to ten times more patients than their current therapies. Treprostinil SMI is still in the investigational stage and not yet approved for any use.