Symbicort sees similar safety to budesonide

New study results showed that AstraZeneca's Symbicort (budesonide/formoterol fumarate dehydrate) inhalation aerosol asthma treatement had a safety profile similar to one of its mono-components, budesonide, and is well tolerated for up to 52 weeks.

The Anglo-Swedish drug major's blockbuster consists of budesonide, the most widely-studied inhaled corticosteroid, and formoterol, a rapid- and long-acting beta 2-agonist. In first-quarter 2008, it generated sales of $471.0 million worldwide, up 21% year-on-year. The study, which will feature in the September issue of Allergy and Asthma Proceedings, examined two doses of Symbicort, including twice its highest recommended dose, compared to budesonide, in 708 patients aged 12 years and older.

In the trial, the percentage of subjects with at least one asthma exacerbation was significantly lower with both doses of Symbicort versus budesonide and the proportion that experienced any adverse events were similar for either product. In the USA, Symbicort is currently indicated for the long-term maintenance treatment of asthma in patients 12 years of age and older.