Theravance and Mylan have announced postive results from their Phase 3 trial of revefenacin (TD-4208), an investigational treatment for chronic obstructive pulmonary disease (COPD).
Revefenacin is a once-daily nebulized long-acting muscarinic antagonist (LAMA). The Phase 3 randomized, active-controlled, parallel group trial was designed to evaluate the safety and tolerability of 2 doses of revefenacin (88mcg or 175mcg inhaled once daily). A total of 1,055 COPD patients took part in the trial which lasted for 52 weeks. Tiotropium (Spiriva) was used as the standard of care comparator, and half of the patients in the study were using other COPD therapies such as LABA or LABA/inhaled corticosteroids.
Results found that rates of COPD exacerbations were lowest in the 175mcg treatment arm. Also, the adverse events and serious adverse events in the revefenacin group were comparable to the tiotropium group. Anti-muscarinic side effects (eg, dry mouth, constipation) were lowest in the 175mcg group and most common adverse events were exacerbations, nasopharyngitis, upper respiratory tract infections, and cough.
Data from this Phase 3 safety study as well as previously reported Phase 3 efficacy data involving over 1,250 patients with moderate to very severe COPD, will be used to support the New Drug Application (NDA) submission to the Food and Drug Administration (FDA).
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