Re: Farmas USA
ARNA:
Razonamiento de que Lorcaserin es seguro y conclusion de que si la FDA pidiera mas test de seguridad serian post aprobacion.
"It was the FDA that wanted ARNA to do its clinical trials on Lorcaserin alone without another combination fat burner type drug. So, it must have been done that way for a reason. IMO, they wanted to test it isolated since it is a NOVEL drug with a receptor inhibitor. The receptor that Lorcaserin inhibits is NOT the same one that Phen/Fen did which is now known to be associated with H/V problem. During all of Lorcaserins testing there has never been a SAE, or even a case associated with H/V problems. So, they can conclude that this receptor that lorcaserin inhibits will not adversely affect H/V function, and that it inhibits only the targeted receptor and not those associated with previous problems. What we can conclude with this is that Lorcaserin meets the FDA guidelines even without the presence of a fat burner type drug and that it is safe. More than likely only requiring post approval studies to make absolutely certain that it is safe. How can they not be happy with the efficacy results when it was not even given the same opportunity of success as the other canidates which included fat burner drugs? Lorcaserin appetite surpressant is far superior than the other canidates. Which along with safety is why it will be approved"
