The US Food and Drug Administration have approved the once-daily bronchodilator inhalation spray olodaterol (Striverdi Respimat) for the long-term treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.
The announcement follows a recommendation in February 2013 from the Pulmonary-Allergy Drugs Advisory Committee (PADAC), of the US Food and Drug Administration (FDA), that the clinical data submitted with the new drug application provided substantial and convincing evidence to support the approval of Boehringer Ingelheim's new drug.
Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, says in the press announcement that:
"The availability of this new long-term maintenance medication provides an additional treatment option for the millions of Americans who suffer with COPD."
COPD is a serious lung disease and the third leading cause of death among Americans. People with COPD have difficulty breathing, experience wheezing, chest tightness, cough and shortness of breath.
The condition gets worse over time and treatment is made more difficult because COPD is often accompanied by other serious medical conditions, such as heart disease, diabetes, osteoporosis and depression.
In trial, COPD patients treated with olodaterol showed improved lung function
Olodaterol, classed as a long-acting beta-adrenergic agonist (LABA), works by helping the muscles around the airways in the lungs to stay relaxed and relieve symptoms.
In a study involving over 3,000 patients with COPD, those treated with the drug showed improved lung function, compared with those treated with placebo.
The most common side effects seen in participants who took the drug included runny nose, bronchitis, cough, upper respiratory tract infection, urinary tract infection, rash, diarrhea, dizziness, back pain and joint pain.
The FDA says the drug "should not be used in patients with acutely deteriorating COPD and may cause serious side effects, including narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects."
Olodaterol not approved for treatment of people with asthma
The federal agency also warns that the drug's safety and effectiveness in people with asthma has not been established, and it is not approved for the treatment of people with asthma. In addition, the drug should not be used as a rescue therapy for sudden breathing problems or acute bronchospasm.
The drug carries a boxed warning that this class of drug is known to increase the risk of asthma-related deaths. The patient medication guide approved with the drug has instructions on how to use it and describes the risks of taking it.
Olodaterol is also currently undergoing trial as part of a fixed-dose combination treatment in conjunction with tiotropium, a long-acting muscarinic antagonist (LAMA), for the treatment of COPD. Promising results of a phase 3 trial of the investigational treatment were presented in May 2014 to an International Congress of the American Thoracic Society (ATS) in San Diego, CA.