Revefenacin: Phase III data
Top-line data from a pair of identical, double-blind, U.S. Phase III trials in a combined total of >1,250 patients with moderate to very severe COPD showed that 88 and 175 ug once-daily doses of inhaled revefenacin via nebulizer each met the primary endpoint of improving trough FEV1 after 12 weeks compared to placebo in both trials. Pooled data from the trials showed that low- and high-dose revefenacin improved trough FEV1 by 118 and 145 mL, respectively, compared to placebo. Low- and high-dose revefenacin also improved FEV1 by 92 and 135 mL in patients using background long-acting beta agonist (LABA)-containing therapies and by 131 and 150 mL in patients not using concomitant LABA therapy. The product was generally well tolerated with exacerbations, cough, dyspnea and headache reported as the most common adverse events...