COPD gains first nebulized beta2 agonist

November 20, 2006

Arformoterol (Brovana, Sepracor) inhalation solution, 15 mcg, is the first inhaled long-acting beta2-adrenergic agonist to be approved for use with a nebulizer. It was approved for long-term, twice-daily (morning and evening) maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The company plans to launch the product during the second quarter of 2007.

Laura Smoot, Pharm.D., a clinical assistant professor at the James I. Harrison School of Pharmacy at Auburn University in Alabama, said arformoterol is the (R,R)-enantiomer of formoterol, which contains both the (R,R) and (S,S)-enantiomers. It also has a twofold greater potency than the racemic formoterol.

Sepracor cautions that arformoterol should not be used in conjunction with other inhaled long-acting beta2-adrenergic agonists, or medications containing long-acting beta2-adrenergic agonists. Arformoterol, like other beta2-adrenergic agonists, should be used with extreme caution in those taking monoamine oxidase inhibitors, tricyclic antidepressants, and drugs that prolong the QTc interval.

The manufacturer also advises that arformoterol is inappropriate in those with deteriorating COPD, and increasing the daily dosage of arformoterol beyond 15 mcg administered twice daily is not recommended. Dosage adjustment is not required in those with renal and hepatic impairment, but Sepracor recommends close monitoring for those with hepatic impairment.

The company recommends that arformoterol, as is true of other sympathomimetic amines, be used with caution in those with cardiovascular disorders, particularly coronary insufficiency, cardiac arrhythmias, and hypertension.

Smoot said that pain, chest pain, back pain, and diarrhea were among the most common adverse events reported during clinical trials.

Arformoterol is supplied in single-strength (15 mcg of arformoterol, equivalent to 22 mcg of arformoterol tartrate) unit-dose vials individually wrapped in foil, containing 2 ml of a sterile solution.

Timothy Myers, B.S., RRT-NPS, the director of asthma and diagnostic care and pediatric respiratory services at Rainbow Babies & Children's Hospital in Cleveland, cited several advantages of nebulized medications over drugs administered with an inhaler, including the fact that normal breathing patterns can be used and an inspiratory pause is not required for efficacy. He added that these characteristics make nebulized medications use-ful in very elderly or debilitated patients.