Thursday, August 5, 2010
Keeping You in the Loop
First and foremost, the FDA recently approved Influenza Vaccines for the 2010-2011 flu season. Multiple sites within the PMG network have conducted trials on these vaccines, so congratulations to all of the participants and sites that have helped to ensure that individuals can effectively combat the flu this flu season! Click here to read more.
A Daiichi-Sankyo medication studied at nearly every PMG site, just received approval for high blood pressure. Tribenzor is a once-daily medication that combines three commonly used high blood pressure drugs, so it will hopefully simplify treatment for many individuals. Hats off to the participants and sites that are responsible for the availability of Tribenzor to the general public! Click here to learn more about Tribenzor.
An update is available on an obesity drug called lorcaserin that was studied at the New Hanover and Triangle sites. Arena Pharmaceuticals and Eisai Pharmaceuticals have reported that lorcaserin demonstrated significant weight loss in the BLOOM studies, as well as improved maintenence of weight loss. Lorcaserin is currently under FDA review with an expected approval date of October 22, 2010. Click here for more details on the BLOOM trials.
A diabetes drug being developed by Xoma Pharmaceuticals, which under study at several sites in the network, has been identified to have a completely new way of treating Type 2 Diabetes. This drug is early in it's development (currently in Phase II), so the trials are being conducted to ensure efficacy and safety in Type 2 Diabetics. Click here to learn more.
We have an update on the development of LEVADEX, an orally inhaled migraine therapy being developed by MAP Pharmaceuticals. The following sites participated in the LEVADEX trials, Metrolina, New Hanover, Palmetto, Piedmont and TriCities. MAP expects to be able to submit data to the FDA for review (and subsequent approval) in the first half of 2011. Click here to read more.
An Alzheimer's Disease medication called Dimebon, which was studied at Piedmont Medical Research did not meet study endpoints; so although the drug was well-tolerated in participants, it didn't work better than the placebo. This is a good example of why placebos are used in clinical trials. Had there not been a placebo group in this trial, there would be nothing with which to compare dimebon to in the trial. Pfizer is currently evaluating the dimebon development program overall, but state they recognize the significant medical need and are commited to advancing treatment options for patients with Alzheimer's Disease. Click here for more information about the Dimebon results.
Without clinical trial participants, whom we fondly refer to as our "Medical Heroes", we would never know whether these medications represent new and better ways to treat disease. We love reporting that medications we study ultimately receive approval because it shows participants that they have helped to advance medical science; but we also have to be realistic and recognize that some trials will not ultimately lead to a new treatment for the condition for which it was researched. What we do know though, is that data collected during these trials is so valuable and sometimes uncovers a potential new use for a medication. Every single participant and every single clinical trial, moves medicine forward in one way or another, one step at a time. The entire clinical research team puts their Best Foot Forward to ensure a healthier tomorrow!
Posted by Allison Kelly at 12:09 PM