Tudorza Pressair in COPD - FDA adds data to prescribing information

Circassia Pharmaceuticals announced that the FDA added new data to the Tudorza Pressair (aclidinium bromide inhalation powder) Prescribing Information that includes data from the ASCENT trial showing that Tudorza Pressair reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events (MACE) in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors. Tudorza Pressair is indicated for the maintenance treatment of patients with COPD.

ASCENT was a randomized, double-blind, placebo-controlled of up to 36-months study that evaluated the effect of Tudorza Pressair on MACE and exacerbations in 3,630 patients with moderate-to-very-severe COPD. All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors. This phase IV trial found that, compared to placebo, Tudorza Pressair does not increase MACE and reduced exacerbations in the first year in COPD patients with high cardiovascular risk. Tudorza Pressair is not a rescue medicine and should not be used for treating sudden breathing problems. In this study, adverse reactions occurring at a rate of at least 2% and more common than placebo were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease.