{"id":2308,"date":"2011-09-13T00:00:00","date_gmt":"2011-09-13T00:00:00","guid":{"rendered":"https:\/\/1millionbestdownloads.com\/condition-copd-new-copd-drug-why-an-fda-panel-said-no-but-fda-said-yes\/"},"modified":"2011-09-13T00:00:00","modified_gmt":"2011-09-13T00:00:00","slug":"condition-copd-new-copd-drug-why-an-fda-panel-said-no-but-fda-said-yes","status":"publish","type":"post","link":"https:\/\/1millionbestdownloads.com\/condition-copd-new-copd-drug-why-an-fda-panel-said-no-but-fda-said-yes\/","title":{"rendered":"New COPD Drug: Why an FDA Panel Said No, but FDA Said Yes"},"content":{"rendered":"
Getty ImagesPeople with chronic obstructive pulmonary disease (COPD)—a lung condition thats one of the biggest killers in the nation—now have a new treatment option: a once-a-day pill called Daliresp (roflumilast).<\/p>\n
The U.S. Food and Drug Administration (FDA) approved the drug in March 2011. But the process was not smooth sailing. In 2010, an FDA advisory panel recommended against approving the drug. Even though the FDA almost always follows the advice of such expert panels, the agency went ahead and gave Daliresp a thumbs up anyway.<\/p>\n
So should COPD patients be worried about taking the drug? No, says FDA spokesperson Morgan Liscinsky. According to Liscinsky, even though the FDA panel recommended against the drugs approval, "the final 10-to-5 vote by the advisory committee does not fully describe how the committee members viewed the evidence to support the safety and efficacy of roflumilast."<\/p>\n
On separate questions, the panel had actually voted 9-to-6 in favor of adequate demonstration of efficacy (meaning that the studies suggested that the drug actually worked) and, again, 9-to-6 in favor of adequate demonstration of safety, says Liscinsky. "There was considerable positive opinion regarding its safety or efficacy."<\/p>\n
But the committee had been asked to vote on a broader indication for the "maintenance treatment of COPD," which Liscinsky says the data did not support, rather than a more narrow use for treating the symptoms of exacerbations. Exacerbations are periods when COPD symptoms, such as shortness of breath<\/a> and coughing, can get much worse due to an infection or other problem, and patients can wind up in the hospital.<\/p>\n Another major issue that held the panel back from giving the drug its blessing was that the group had to vote on whether it should be approved for a larger group of COPD patients. “People with mild disease could have been included in the [advisory committees] vote, and thats the major difference,” says Stephen Rennard, MD, a professor of medicine at the University of Nebraska Medical Center, in Omaha. Dr. Rennard is also a consultant to Forest Laboratories and Nycomed, the U.S. and European\/Canadian companies, respectively, that own the license for roflumilast.<\/p>\n When the FDA finally approved Daliresp, it was to treat bronchitis-related symptoms, such as cough and excess mucous in people with severe or very severe COPD who have a history of exacerbations.<\/p>\n Daliresp is not approved for people who have COPD involving emphysema or for patients younger than 18. (The study was conducted in patients 40 and older.)<\/p>\n Next Page: Side effects of Daliresp<\/a> [ pagebreak ]Dr. Rennard, who was a presenter at the FDA advisory committee in 2010, thinks that "if the committee had voted on the narrower indication, it probably would have gone through,” meaning the advisory committee would have said yes to the drugs approval for patients with at least severe COPD. He adds that it was in the severe and very severe COPD groups that Daliresp trials found the drug to have the clearest benefit.<\/p>\n Of the 12 million people in the U.S. who are estimated to have COPD, Dr. Rennard says that approximately 3 million have severe COPD and chronic bronchitis and could benefit from Daliresp.<\/p>\n Side effects of Daliresp<\/b> On the other hand, 14% of patients in the trial stopped taking the drug as a result of side effects, versus 12% in the control group. The most common side effects were gastrointestinal problems such as nausea and diarrhea, some loss of appetite and weight loss, and back pain<\/a> and headaches.<\/p>\n In addition, there may be a risk of psychiatric problems, including insomnia, anxiety, and depression. Among the nearly 12,000 patients who participated in Daliresp trials, there have been three suicides and two suicide attempts in the group receiving Daliresp compared with no suicides or suicide attempts in the placebo group. The patient medication guide that will be packaged with Daliresp states that doctors should weigh the risks and benefits before prescribing the drug to patients with a history of depression or suicidal behavior.<\/p>\n And there may be a higher cancer incidence among people taking Daliresp. Of study subjects who developed tumors, 60% were in the Daliresp group and 40% in the placebo group. However panelists were reportedly skeptical that Daliresp actually increases the risk of cancer since the tumors were most likely present before the study began.<\/p>\n
The main trial on Daliresp, funded by Nycomed, was published in 2009 in the Lancet<\/i>. It found that the drug improved lung function and resulted in a 17% reduction in the number of exacerbations.<\/p>\n