Four Studies Published in The Lancet Show Roflumilast (Daxas®), a New Oral Approach to COPD, Improves Lung Function & Reduce...
August 27 2009 - 6:35PM
Business Wire
Forest Laboratories, Inc. (NYSE: FRX), an international
pharmaceutical manufacturer and marketer and Nycomed, a privately
owned pharmaceutical company, today announced that results of four
phase III trials have been published in the prestigious
peer-reviewed medical journal The Lancet showing that roflumilast,
a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and
reduced exacerbations in patients with moderate to severe COPD.
COPD is an under-diagnosed progressive lung disease that may
lead to death. Worldwide, COPD kills four people every minute and
the World Health Organization (WHO) predicts that it will be the
third leading cause of death by 2030. WHO estimates that 80 million
people have moderate to severe COPD.
Roflumilast, a once-a-day oral tablet, would be the first in an
entirely new class of treatment for COPD if it receives regulatory
approval from the authorities in Europe (EMEA) and the US (FDA).
The phase III placebo-controlled trials of roflumilast evaluated
the treatment in two 12-month (Lancet 2009; 374: 685–694) and two
six-month studies (Lancet 2009; 374: 695–703), involving 4,500
patients in ten countries. Details of the results of the four
studies will be published in The Lancet on August 29 (data and
information under embargo until Friday, August 28 at 00:01am
GMT).
The two 12-month studies published in The Lancet demonstrated
that roflumilast produced a statistically significant and
clinically relevant reduction in exacerbations (lung attacks that
need treatment with systemic steroids or lead to hospitalisation),
even for patients who were also taking long-acting bronchodilators.
The studies showed a reduction in moderate to severe exacerbations
by 17 percent per patient per year (rate of 1.14 events per year
with roflumilast vs. 1.37 per year with placebo, p
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