Developing new medications and getting them from the lab to your neighborhood pharmacy (or mailbox) as safe and effective - is a long, complicated process, requiring a great deal of care. You may have heard about this new medication. Here’s a brief report.
What is Relovair?
Relovair is a new medication for COPD that is currently being tested in people who have COPD. It is combination of two medications: Fluticasone Furoate (an inhaled corticosteroid which is the scientific name for Flovent®) and Vilanterol Trifenatate, (a long-acting beta2 agonist, or L.A.B.A., that is in the same category as Serevent® and Foradil®).
Relovair is meant to be taken only once a day. Patients using it in the studies are being dosed using a single step activation inhaler.
Relovair is being developed by Glaxo Smith Kline, the makers of Advair®, Flovent®, Serevent®, and Ventolin® HFA, among others. GSK is working on Relovair in partnership with a company by the name of Theravance.
Studies look at lung function
Two six-month trials testing the effectiveness and safety of Relovair have been completed. In the early phase of the trials, results have not been quite as good as hoped, although they do pass regulatory approval.
Relovair has been tested against placebo, looking at lung function in about 2,200 patients with moderate to severe COPD. Note: A placebo contains no medication. For example, a placebo inhaler would contain only propellant, but no active ingredient. Placebos are used in research studies so patients in the study do not know if they are taking the real medication or not.
- In patients using Relovair vs. placebo, the FEV1 (the volume of air they blew out in the first second of a long exhalation – a key indicator for severity of COPD) was statistically better.
- In patients using Relovair vs. Fluticasone, the inhaled corticosteroid component only, the FEV1 was also statistically better.
- But in tests with Relovair vs. Valanterol, the long acting bronchodilator component alone, although results showed that lung function was better with Relovair, it was not as statistically significant.
Studies looking at other aspects of life with COPD
More studies are yet to be completed. One is a large study being done in 16,000 COPD patients.
Each study has a goal, a certain aspect of life with COPD that is being tested.
The primary goal of this phase is to assess the potential for Relovair to improve survival in patients who have both COPD and a history of, or are at risk from, cardiovascular disease.
A secondary goal will evaluate the effect of Relovair compared with placebo on the rate of decline in lung function, as well as on cardiovascular problems including cardiovascular death, heart attacks and strokes. One of the things they’ll be assessing in particular is arterial wall stiffness.
The studies as a whole are being conducted widely - across 1,100 global sites.
What’s the timeline?
So, what does this mean for you? When might Relovair become available? Don’t get too excited just yet! It takes a while to make sure that new medications are safe and effective before they reach your pharmacy. The makers of Relovair will begin the long process of approval in the middle of this year, 2012. They will be filing for use in the treatment of COPD in the U.S. and Europe – and as a treatment for asthma in Europe.