New Drug Shows Positive Results in Crucial Studies

Relovair, an inhaled drug candidate from GlaxoSmithKline (GSK), has shown positive results in two crucial studies evaluating the compound’s effectiveness in treating chronic obstructive pulmonary disease (COPD). That is according to a recent statement released by the London-based pharmaceutical company.

GSK and drug partner Theravance said that both studies, which evaluated the compound in 6,000 patients with moderate to severe COPD, showed that Relovair demonstrated statistically significant improvements in patients compared to a placebo. These results boost the compound’s chances of becoming the successor to GSK’s blockbuster asthma and COPD drug, ADVAIR, whose patents have expired. ADVAIR, which generated about $8.4 billion in 2010 sales, is GSK’s top-selling product.

Both studies were placebo-controlled, double-blind, parallel-group studies and evaluated two separate measures of lung function: improvements in lung function over the first four hours post-dose on day 168 and the end-of-dose trough lung function on day 169. For pre-specified co-primary endpoints analyses, both studies show statistically significant improvements for Relovair compared with the placebo.

The studies also revealed that the most common adverse events across all treatments, including placebo, were nasopharyngitis, upper respiratory tract infection and headache. There were no clinically relevant effects seen in laboratory measures or vital signs.

Developed as a once-per-day inhaled drug, Relovair pairs ADVAIR’s main ingredient, fluticasone, with another compound, vilanterol. It is also being studied as an asthma treatment. From here, the two six-month studies will be combined with a separate 12-month study and included in the company’s regulatory submissions. The full results of all studies will be presented at future scientific meetings.

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