New inhaled drug for COPD wins FDA approval
Date: Aug-01-2014 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 FDA have approved an inhaled drug for treatment of COPD.
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.
Written by Catharine Paddock PhD
View all articles written by Catharine, or follow her on:
Courtesy: Medical News Today
Note: Any medical information available in this news section is not intended as a substitute for informed medical
advice and you should not take any action before consulting with a health care professional.