FDA approved new COPD drug
  • Tue, 07/24/2012 - 12:50pm

The U.S. Food and Drug Administration (FDA) announced Monday that it has approved Tudorza Pressair for the treatment of bronchospasm, a narrowing of the respiratory airway associated with chronic obstructive pulmonary disease (COPD).

According to the FDA’s press release, “[C]igarette smoking is the leading cause of COPD” and “COPD is the fourth leading cause of death in the United States.” Bloomberg News reported that nearly 12 million people are diagnosed with COPD each year.

Forest Laboratories’ long-lasting dry powder inhaler drug can help loosen muscles around the lungs and increase air flow when taken twice daily, the press release stated.

"COPD is a serious disease that gets worse over time," said Dr. Curtis Rosebraugh of the FDA's Center for Drug Evaluation and Research. "The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease."

COPD makes breathing difficult and worsens over time. It can cause a person to cough large amounts of mucus or become short of breath. He or she may also feel tightness in the chest or pressure behind the eyes.

According to MedPage Today, an FDA panel voted 12-2 to approve Tudorza but felt a postmarketing study needed to be conducted in order to determine the drug’s cardiovascular risk.

The study observed 1,276 patients under age 40 in three randomized clinical trials. In all three trials, Turdora demonstrated the capability to significantly increase airflow through the lungs compared to the placebo.

Bloomberg News stated that Tudorza is not a “rescue therapy” for sudden breathing problems like asthma and should not be taken by people under 18. The FDA stated that Tudorza may not always prevent bronchospasm and, in fact, it may cause the condition, which is called paradoxical bronchospasm.


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