Symbicort Turbuhaler now approved for “prn” use as “anti-inflammatory reliever therapy” in mild persistent asthma

AstraZeneca has received Health Canada approval for a third indication for Symbicort Turbuhaler (budesonide/formoterol fumarate dihydrate dry powder for oral inhalation). The combination product is now indicated for use in patients 12 years of age or older as “anti-inflammatory reliever therapy,” in addition to the existing indications as “anti-inflammatory reliever plus maintenance therapy” and “maintenance therapy.”(1)The new indication for use as anti-inflammatory reliever therapy applies to patients 12 years of age or older with mild persistent asthma. In this situation, Symbicort 200 Turbuhaler is used “prn” (as needed) for relief of asthma symptoms when they occur.(1)The existing indication as anti-inflammatory reliever plus maintenance therapy applies to patients 12 years of age or older with moderate or severe asthma. These patients can use Symbicort 100 or 200 Turbuhaler as daily maintenance therapy and as needed for relief of asthma symptoms when they occur. The other existing indication for use as maintenance therapy applies to patients 12 years of age or older with moderate or severe asthma. These patients can use Symbicort Turbuhaler as a fixed-dose daily treatment with a separate short-acting bronchodilator for relief of symptoms when they occur.(1)The new indication for use as anti-inflammatory reliever therapy in patients with mild persistent asthma somewhat reflects the latest Global Initiative for Asthma (GINA) guidelines for asthma management. In the 2019 GINA guidelines, the preferred treatment for adults and adolescents with mild asthma (i.e., symptoms < twice per month and no exacerbation risk factors) is low-dose combination inhaled corticosteroid–formoterol therapy (e.g., budesonide–formoterol in a single inhaler), taken as needed (prn) to relieve symptoms, and if needed before exercise.(2)The Symbicort Turbuhaler product monograph notes that Symbicort has not been evaluated in patients with asthma that can be managed by occasional use of a rapid onset, short duration, inhaled beta2-agonist. However, the 2019 GINA guidelines state that, for safety reasons, a short-acting beta-agonist (SABA) alone is no longer recommended for treating mild asthma symptoms in adolescents or adults; this is based on strong evidence that SABA treatment alone, although highly effective in providing symptom relief, increases the risk of severe asthma exacerbations and asthma-related death.(2) This change in the GINA guidelines (i.e., no longer recommending a SABA alone in mild asthma, but recommending low-dose combination inhaled corticosteroid–formoterol therapy instead [e.g., budesonide–formoterol in a single inhaler], taken as needed to relieve symptoms and if needed before exercise), has been described as the most fundamental change in asthma management in the past 30 years.(3)Note that formoterol (in Symbicort) is a long-acting beta-agonist (LABA), but it has a rapid onset of action. As a reliever medication, it is as effective as a SABA. However, regular or frequent use of a LABA such as formoterol without an inhaled corticosteroid is strongly discouraged in the GINA guidelines because of the risk of asthma exacerbations.(2)The GINA guidelines continue to recommend a SABA alone as the reliever of choice in children. Pediatric studies of as-needed ICS–formoterol still need to be conducted.(2,3)ReferencesAstraZeneca Canada Inc. Symbicort Turbuhaler (budesonide/formoterol fumarate dihydrate dry powder for oral inhalation) product monograph. Mississauga, ON; September 24, 2019. https://pdf.hres.ca/dpd_pm/00053277.PDF (accessed October 2, 2019).Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, updated 2019. https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf (accessed October 2, 2019).Reddel HK, FitzGerald M, Bateman ED, et al. GINA 2019: a fundamental change in asthma management. Treatment of asthma with short-acting bronchodilators alone is no longer recommended for adults and adolescents. Eur Respir J 2019;53:1901046. https://erj.ersjournals.com/content/erj/53/6/1901046.full.pdf (accessed October 2, 2019).

Symbicort Turbuhaler now approved for “prn” use as “anti-inflammatory reliever therapy” in mild persistent asthma

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