The drug has been accredited for once daily use and can be
utilized over a long period of time.
"The availability of this new long-term maintenance
medication offers an additional treatment choices for the millions of people
who suffer from COPD," noted Curtis Rosebraugh, MD, MPH, director of the Office
of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research in
the statement.
As a long-acting beta adrenergic agonist (LABA) Striverdi
Respimat is designed to help keep muscles around a patient's airways relaxed in
order to help manage their symptoms.
The drug was examined in a study that included 1304 patients
with those who were prescribed the drug showing more improvement than those
taking a placebo.
Symptoms of COPD can comprise wheezing, coughing, chest tightness and shortness
of breath.
According to the National Heart Lung and Blood Institute, it
is the third leading cause of death in the US.
Striverdi Respimat carries a boxed caution that notes an
increased risk of asthma-related deaths that comes with LABAs.
The FDA stated, the safety and effectiveness for using the
drug for the treatment of asthma has not been established and it is not
currently an officially accepted use. It also should not be used as a rescue
therapy.
The drug is also not advised for patients with acutely deteriorating COPD as it
may produce serious side effects including narrowing and obstruction of the
respiratory airway (paradoxical bronchospasm) and other cardiovascular effects.
Side effects associated with the drug include runny nose, upper respiratory
tract infections, bronchitis, cough, urinary tract infection, dizziness, rash,
diarrhea, back pain and joint pain.
The drug is supplied by Boehringer Ingelheim Pharmaceuticals, Inc. of
Ridgefield, CT.
Source: Medindia
