Theravance Biopharma recently announced that the Phase 4 study results for their inhalation solution, Yupelri revefenacin, did not meet its primary endpoint. The once-daily, nebulized long-acting muscarinic antagonist is FDA-approved for the maintenance treatment of severe to very severe chronic obstructive pulmonary disease (COPD).
During the study, there was no statistically significant difference observed in the primary endpoint, which measured the change from baseline in trough forced expiratory volume in one second at day 85. Interestingly, both Yupelri and Spiriva HandiHaler showcased similar improvements in lung function throughout the trial.
However, it should be noted that Yupelri demonstrated a consistent level of safety and tolerability, aligning with previous clinical studies. While Yupelri is specifically approved for COPD maintenance treatment in the U.S., Spiriva HandiHaler has a broader approval for long-term, once-daily maintenance treatment of bronchospasm associated with COPD, as well as reducing COPD exacerbations.
These recent findings emphasize the need for further research and development to enhance the efficacy of Yupelri in order to meet the expectations set forth by Theravance Biopharma.
