Some here have opined that the pending launch(probably in the 2nd half of 2013)of trokendi by SUPN will achieve significant comercial success as a generic substitute providing one of the components(time released topiramate) for FDA approved obesity medication Qsymia.This assumption is based on the fact that CURRENTLY a fair number of physicians are prescribing topiramate and pentlrmine OFF LABEL for treatment of obesity.While it is logical to assume that SOME will continue to prescribe the two pill generic combo of topiramate and phentIrmine and that some will substitute trokendi because of its similar dose availability and time released property to Qsymia,this number should be quite small.With physicians NOW having an FDA approved single pill formulation(Qsymia)of time released topiramate and pentIrmine to be administered under specific dosing and titration requirement as well as a detailed REMS program, the risk involved for patients and physicians taking the OFF LABEL route is now unecessary and unwarranted.The FDA provides valuable function and its recommendations and regulations should and will be taken seriously by most.IMHHO
Fair enough walk, You're along time vvus long and your view is that approval of qsymia will forestall generic competition. In practice, generic competition happens all the time. I do not suggest that SUPN will kill qsymia sales; but rather, they could shave off a few percentage points. Perhaps not a big deal for vvus - but potentially a huge boost to the top line for SUPN.
respectfuly, I don`t see trokendi doing much past the market it was approved and intended for. It would seem that the small group that continue to prescribe OFF LABEL topo and phen for weight loss will continue to use whatever they currently use.The time release aspect has even been downplayed on this board bc of the long half life for topo.If a physician doesn`t care enough to switch to the FDA approved drug(qsymia) why would they care enough to switch to the time released trokendi for the topo component? IMHHO YES I AM LONG VIVUS