AstraZeneca announced that the Food and Drug Administration (FDA) has approved Symbicort (budesonide/formoterol fumarate dihydrate) 160/4.5mcg to reduce exacerbations of chronic obstructive pulmonary disease (COPD).

The FDA approval was supported by data from two Phase 3b studies (Study 3 [RISE] and Study 4). The studies examined the efficacy of Symbicort pressurized metered dose inhaler (pMDI) 160/4.5mcg vs. formoterol 4.5mcg in reducing COPD exacerbations in adults with moderate to very severe COPD. In Study 3, patients treated with Symbicort 160/4.5mcg had a significantly lower rate of moderate/severe COPD exacerbations vs. patients treated with formoterol 4.5mcg (26% reduction, 95% CI: 9, 39). In Study 4, Symbicort-treated patients experienced a significantly lower annual rate of exacerbations vs. formoterol-treated patients (35% reduction, 95% CI: 20, 47).

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Symbicort combines budesonide, a corticosteroid, and formoterol fumarate dihydrate, a long-acting beta-2 agonist (LABA). It is already approved as maintenance treatment for asthma in patients ≥6 years old not adequately controlled on other asthma-controller medications (eg, low-medium dose inhaled corticosteroids) or those whose disease severity clearly warrants starting treatment with two maintenance therapies; and as maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and emphysema.

It is available as 80/4.5mcg and 160/4.5mcg strength inhalers; only the 160/4.5mcg strength is indicated for use in COPD conditions. 

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