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

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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.