Theravance Biopharma, Inc. (TBPH) announced results from the Phase 4 PIFR-2 study of YUPELRI inhalation solution, the nebulized long-acting muscarinic antagonist approved in the U.S. for maintenance treatment of Chronic Obstructive Pulmonary Disease or COPD. The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler on the primary endpoint, change from baseline in trough forced expiratory volume in one second at Day 85.
CEO Rick Winningham said: "While the primary endpoint in the Phase 4 PIFR-2 study was not met, YUPELRI demonstrated an efficacy and safety profile consistent with its performance in other clinical studies."
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