Monday, Forest Laboratories, Inc. (FRX) and privately owned pharmaceutical company Nycomed said that the U.S. Food and Drug Administration issued a complete response letter regarding the New Drug Application for roflumilast. Roflumilast was reviewed as a potential treatment to reduce chronic obstructive pulmonary disease exacerbations associated with chronic bronchitis in patients at risk for exacerbations.
New York-based Forest Laboratories said that the FDA has requested certain additional information and analyses in the complete response letter. However, no additional patient trials have been requested for the continued review of the New Drug Application or NDA. Forest and Nycomed said that they will work with the FDA to address the outstanding matters and expect to respond to the FDA during the third calendar quarter of 2010.
Chronic obstructive pulmonary disease or COPD is an under-diagnosed, progressive lung disease that is the fourth leading cause of death in the U.S. Approximately 12 million people are currently diagnosed with the disease and an additional 14 million are likely to have the disease. Of the patients diagnosed with COPD, over 80% or 9.8 million have COPD associated with chronic bronchitis.
Symptoms of the disease include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms can last several weeks and requires substantial medical intervention, including hospitalization. It can result in lung function decline, and increased risk of death.
According to the company, Roflumilast is a phosphodiesterase 4 or PDE4 enzyme inhibitor that targets the underlying inflammation associated with COPD. If approved, the therapy, which is a once-a-day oral tablet, will be the first in a new class of treatment for COPD. The drug is not a steroid.
FRX closed Monday's last trade at $26.19, down $0.35 or 1.32%, on a volume of 5.10 million shares on the New York Stock Exchange.
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