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Oct 11, 2006

GSK Submits SDA for Advair in COPD

  • GlaxoSmithKline submitted a supplemental new drug application to expand labeling for Advair Diskus® (fluticasone propionate and salmeterol inhalation powder), based on studies that showed reduced death risk and rate of chronic obstructive pulmonary disease (COPD) exacerbations.

    Results from GSK’s three-year TORCH study (TOwards a Revolution in COPD Health) showed a 17.5% reduction in risk of death from any cause over three years for patients receiving Advair 500/50 as compared with patients on placebo(p=0.052). In addition, it reduced the rate of COPD exacerbations by 25% compared with placebo (p<0.001). Advair also improved quality of life when compared to placebo (p<0.001), although it did not meet the predefined magnitude of difference.

    The company observed, however, that Advair was associated with increased reporting of pneumonia compared with placebo (p<0.001). Other adverse events (e.g. candidiasis, dysphonia, contusion) generally appear consistent with those seen in previous studies of Advair in patients with COPD.

    Advair 250/50 is currently indicated for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis.

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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

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