The Hospice Clinician Blog

The FDA has approved Tudorza Pressair (generic name aclidinium bromide), a twice-daily inhaled long-acting anticholinergic bronchodilator indicated for COPD maintenance therapy. Tudorza Pressair is distributed by Forest Pharmaceuticals and is expected to be available in the last quarter of 2012.

The safety and efficacy of aclidinium were demonstrated in three randomized, placebo-controlled clinical trials that included 1,276 patients ages 40 and older with COPD. Aclidinium joins one other long-acting anticholinergic bronchodilator currently on the market – tiotropium (Spiriva). The main difference between aclidinium and tiotropium is that aclidinium is dosed twice daily while tiotropium is dosed just once per day. For many patients, once daily dosing is preferred due to convenience. But for patients whose symptoms are particularly problematic at nighttime or in the early morning, twice-daily aclidinium may provide an advantage. In clinical trials, patients using twice-daily aclidinium had better lung function and reduced symptoms during the nighttime hours than patients using once-daily tiotropium.

Aclidinium has been well tolerated in clinical trials, with anticholinergic side effects, such as constipation and dry mouth, being similar to placebo. The most common side effects reported by patients using aclidinium include headache, inflammation of the nasal passage (nasopharyngitis), and cough. FDA's safety review of the product focused on cardiovascular risks because of concerns previously raised about tiotropium. In 2008, the FDA started a safety review of tiotropium after receiving information from clinical studies that suggested the medicine might be associated with a higher stroke risk, but in 2010 the FDA cleared tiotropium of increasing stroke or heart problems. Similarly, Tudorza has not been found to cause increased risk of cardiovascular side effects.

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