Olodaterol Approved for COPD
BETHESDA, MD 01 Aug 2014— FDA 
and Boehringer Ingelheim today announced the approval of olodaterol oral inhalation spray as a long-term, once-daily maintenance bronchodilator to relieve airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
The long-acting β2-adrenergic agonist (LABA) has not been studied for the treatment of asthma or acute deterioration of COPD and is not indicated for those conditions. Olodaterol is contraindicated for the treatment of COPD in patients with asthma who are not using a long-term asthma control medication.
Boehringer Ingelheim will market the product as Striverdi Respimat, with Respimat referring to the propellant-free, soft-mist inhaler device.
A boxed warning in the labeling (PDF) for the product states that olodaterol, like other LABAs, increases the risk of asthma-related death.
This information is reinforced in the FDA-required Medication Guide that must be given to patients each time a prescription for the inhalation spray is dispensed.
Additional warnings in the labeling describe risks of paradoxical bronchospasm, adverse cardiovascular events, hypokalemia, hyperglycemia, and hypersensitivity.
The recommended dosage of olodaterol is two inhalations once daily at the same time of the day. Patients should never exceed this dosage, according to the labeling. No dosage reduction is required for elderly patients or those with mild or moderate liver or kidney impairment.
Patients whose current medication regimen includes the regular use of inhaled, short-acting β2-adrenergic agonists should be told to cease the regular use of these drugs before starting treatment with olodaterol. The labeling for olodaterol gives four times daily as an example of regular use of the short-acting therapy.
Once olodaterol therapy begins, a short-acting β2-adrenergic agonist should be coprescribed but used only for the relief of symptoms of acute respiratory symptoms, sometimes known as rescue therapy, according to the labeling for the LABA.
An increased need for short-acting therapy and decreased effectiveness of that therapy or of olodaterol may indicate deteriorating COPD, which can be deadly and requires a medical evaluation and reassessment of therapy.
The most common adverse events reported by clinical trial participants treated with olodaterol were nasopharyngitis, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain and arthralgia.
Olodaterol will be available in cartons containing one cartridge and one inhaler each in 60- or 28-inhalation package configurations that should be stored at controlled room temperature. Detailed instructions for the proper assembly and use of the product are included in the “Instructions for Use” section of the labeling.