The US FDA have provided marketing approval for the daily once bronchodilator inhalation spray olodaterol (Striverdi Respimat) for the long-term therapy of airflow blockage in individuals with chronic obstructive pulmonary disease(COPD), which includes emphysema and chronic bronchitis.
The statement follows a suggestions in February 2013 from the Pulmonary-Allergy Drugs Advisory Committee (PADAC), of the US FDA, that the clinical data presented with the new drug application(NDA) given significant and convincing proof to support the approval of Boehringer Ingelheim’s new medicine.
Dr. Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s CDER, states in the press statement that:
“The accessibility of this new long term maintenance drug offers an additional therapy option for the large numbers of Americans who endure with COPD.”
COPD is a severe lung disease and one of the major causes of death among People in America. Individuals with COPD have problems in breathing, experience coughing, chest hardness, cough and shortness of breathing.
This situation gets more serious over time and therapy is made more complicated because COPD is usually associated by other severe medical conditions, like as osteoporosis, heart disease, osteoporosis and diabetes.
In study COPD sufferers treated with olodaterol demonstrated enhanced lung function. Olodaterol, classified as a long-acting beta-adrenergic agonist (LABA), functions by supporting the muscles around the air passage in the lungs to remain relaxed and reduce symptoms.
In a trial involving more than 3,000 subjects with COPD, those handled with the drug demonstrated enhanced lung function, in comparison with those treated with placebo.
The most frequent side effects observed in subjects who took the drug included runny nose, cough, bronchitis, diarrhea, urinary tract infection, upper respiratory tract infection, rash, dizziness, back pain and joint pain.
The US FDA states the drug “must not be applied in sufferers with acutely deteriorating COPD and may lead to severe side effects, which includes narrowing and obstruction of the breathing airway (paradoxical bronchospasm) and cardiac effects.”
Olodaterol not approved for therapy of individuals with asthma
The Us FDA also alerts that the drug’s safety and efficiency in individuals with asthma has not been set up, and it is not accepted for the treatment of individuals with asthma. In addition, the drug must not be applied as a rescue therapy for unexpected breathing issues or acute bronchospasm.
The drug carries a boxed warning that this class of drug is known to increase the risk of asthma- associated deaths. The sufferer medication manual 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.