Formoterol fumarate (Perforomist - Dey), a long-acting beta₂-agonist, was recently approved by the FDA as an inhalation solution for nebulization for maintenance treatment of bronchoconstriction associated with chronic obstructive pulmonary disease (COPD). Arformoterol (Brovana), the (R, R)-enantiomer of formoterol, was approved earlier this year for the same indication.

A combination of the corticosteroid mometasone furoate (Asmanex) and the long-acting beta₂-agonist (LABA) formoterol (Foradil) has become available in a single metered-dose inhaler (Dulera – Schering) for treatment of asthma in patients ≥12 years old. It is the third corticosteroid/LABA combination inhaler to become available for this indication in the US. None of these combinations should be used for initial treatment of asthma or for acute treatment of asthma symptoms.

Formoterol fumarate inhalation powder Foradil Aerolizer, a long-acting beta2-adrenergic receptor agonist, has been approved by the FDA for maintenance treatment of asthma and prevention of exercise-induced bronchospasm. The drug has been available in Europe for many years.

A combination of the corticosteroid budesonide and the long-acting beta₂-agonist formoterol (Symbicort - AstraZeneca) has become available in a metered dose inhaler for long-term maintenance treatment of asthma in patients ≥ 12 years old. A combination product that contains fluticasone propionate and salmeterol (Advair) is already available for this indication in the US. Neither one of these combinations is approved for acute treatment of asthma symptoms. A dry powder inhaler formulation of Symbicort has been available in Europe and Canada for several years.

The FDA has approved a fixed-dose combination of the long-acting anticholinergic glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) formoterol (Bevespi Aerosphere – AstraZeneca) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Glycopyrrolate/formoterol is the fourth long-acting anticholinergic/LABA combination to be approved in the US, but the first to become available in a metered-dose inhaler. Glycopyrrolate/indacaterol (Utibron Neohaler), umeclidinium/vilanterol (Anoro Ellipta), and tiotropium/olodaterol (Stiolto...

(Med Lett Drugs Ther 2010; 52:83) The second clinical trial described under the paragraph heading “Clinical Studies” compared the 2 different strengths of the combination with mometasone alone, 400 mcg twice daily, and not with placebo.

The FDA has approved Duaklir Pressair (Circassia), a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and the longacting beta₂-adrenergic agonist (LABA) formoterol fumarate, for maintenance treatment of chronic obstructive pulmonary disease (COPD). Aclidinium/formoterol is the fifth LAMA/LABA combination to be approved in the US for this indication.

Olodaterol (Striverdi Respimat – Boehringer Ingelheim), a new inhaled long-acting beta2-agonist, has been approved by the FDA for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Olodaterol is the third long-acting beta2-agonist to be approved by the FDA for once-daily use; indacaterol (Arcapta Neohaler), which is available as a single agent, and vilanterol, which is available only in fixed-dose combinations with the...

The FDA has approved Airsupra (AstraZeneca), a metered-dose inhaler containing the short-acting beta₂-agonist (SABA) albuterol and the inhaled corticosteroid (ICS) budesonide, for use as needed for treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients ≥18 years old with asthma. Airsupra is the first combination of a SABA and an ICS to become available in the US. It is not approved for use as maintenance therapy.

The FDA has approved aclidinium bromide (Tudorza Pressair – Forest), an orally-inhaled long-acting anticholinergic, for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).