FDA approves COPD once-daily maintenance therapy
August 1, 2014
FDA has approved Striverdi Respimat (olodaterol) inhalation spray for the treatment of chronic obstructive pulmonary disease (COPD). The long-acting beta-adrenergic agonist (LABA) by Boehringer Ingelheim Pharmaceuticals can be used once daily as maintenance therapy, according to FDA.
COPD, the third leading cause of death in the United States, causes serious breathing difficulty and worsens over time. The symptoms include cough, wheezing, chest tightness, and shortness of breath. According to the Centers for Disease Control and Prevention, deaths for COPD have declined in the U.S. population for men from 57.0 per 100,000 in 1999 to 47.6 per 100,000 in 2010. However, for women the death rates for COPD have been steady with 35.3 per 100,000 in 1999 to 36.4 per 100,000 in 2010.
“The availability of this new long-term maintenance medication provides an additional treatment option for the millions of Americans who suffer with COPD,” said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation in the FDA’s Center for Drug Evaluation and Research, in a prepared statement.
The drug’s efficacy and safety was evaluated in more than 3,100 people with COPD. Those treated with Striverdi Respimat had improved lung function compared with the control group.
The drug label has a boxed warning about the increased risk of asthma-related death with LABAs. FDA noted that the drug should not be used to treat asthma and should not be used as a rescue therapy for acute bronchospasm. In addition, individuals with acutely deteriorating COPD should not use Striverdi Respimat because of potential side effects, including paradoxical bronchospasm and cardiovascular effects.
The FDA also approved the drug’s patient medication guide for helping patients and warning of potential risks associated with the medicine.
The most common side effects of Striverdi Respimat include nasopharyngitis, upper respiratory tract infection, bronchitis, cough, urinary tract infection, dizziness, rash, diarrhea, back pain, and join pain.