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Optimer Pharmaceuticals, Inc. (OPTR) Message Board

  • Liquid_Plmber Liquid_Plmber Nov 14, 2008 9:56 AM Flag

    From the VPHM Board - Must Read

    looks like you didn't do your homework duude!...
    you are comparing OPT-80 and Vancocin at the same level..

    Vancocin is not used to treat the mild cases of c-diff...
    that duty is relegated to flagyl aka metronidazole...
    the trials that OPTR did was for these mild cases of c-diff...
    look at the exclusion criteria of the OPTR trials... have that babe you're with do a couple of clicks... yes, yes, clinical trials.gov.. there you will find that they exclude severe or life threatening cases of CDAD... they OPT-ed NOT to fight the tough one...

    Please allow me to inform you that there is super toxic BI strain of C-diff going on...It is causing this uproar you read on the news, see on t.v. etc.. This strain can cause death within 48 hours... Therefore it should not be treated with kid gloves ( such as OPT-80 or metronidazole/flagyl)... You need an ALI to knock'em out... float like a butterfly and sting like a bee... know what i mean?... something that is effective... a REAL drug... and that sir is Vancocin...

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • whaaat?... after i present to you hard data that says they included severe patients in their trials you still don't believe... okay...
      and your contention that dead patients are not evaluable?... did you ever see CSI... or at the very least doctors can write down in their data... 'patient died'

      severe cdad patients is a loose term anyway... it can be interpreted differently from one doctor to the other... sooo, the doctors at IDSA/SHEA came out with a guideline to treat these patients... they now say if you have white blood cell count of 15,000 you are considered severe ... a company came out with faster testing equipment/methods to facilitate this... This bodes well for patients... they are now eligible to be treated with a stronger drug than metronidazole if they have this blood count... as a result they will be dosed sooner and longer from 10 to 14 days... this will improve the cure and recurrence rate... and the drug is... you guessed it.... Vancocin.

      Now Optimer may have done the 'intelligent thing' as you believe... pitting vanco against opt-80 on mild cases of cdad to gain an approval and a foothold... again vanco is not used for this patient population... metro is...

      imo, them doing this will limit their market share... as i understand it, it will cost a lot more to manufacture opt-80 than metro... will a doctor reach out for an expensive drug to treat a non life threatening situation that a 'two buck a dose drug' can treat?...
      opt-80 might find itself between a rock and a hard place... i hope not...

      aloha,
      kamoa

    • wassup bradah lock! how's da surf in hookipa?... i look down the coastline on the road to wailuku and looks like storm surf.. i stay hea in kihei. hope you make it big with optr... me i'm still doing my dd... meanwhile i stay with vphm... kala coming in every quarter... latazz... see you in da water...

      a hui hou,
      kamoa

    • eh kamoa,wea you stay.i stay hea on maui in paia.so wat.local bradas going make out on dis optr.i have been loaded up since april.you sound like one smart hawaiian.just thought i would throw some pidgin in there to make you smile.aloha,loch

    • here's the result of Tolevamer's 1st phase III trial... notice there;s severe cdad and that the recurrent rate is much more superior than opt-80... but obviously they can't run on that one strong suit alone...

      "Among patients who received at least one dose of study drug and a clinical evaluation, overall clinical success rates were much lower with tolevamer than with vancomycin or metronidazole (46.6%, 81.3%, and 72.0%, respectively, P <.001). Tolevamer was also significantly inferior in a subset of 185 patients with severe CDAD (P <.05). In that subset, vancomycin was significantly more effective than metronidazole (84.8% success vs 64.9%, P =.04).

      But among patients who did achieve clinical success, recurrence rates were significantly lower with tolevamer than with the other two drugs -- just 3.4% for tolevamer versus 23.4% for vancomycin and 27.1% for metronidazole (P <.001). Recurrence was defined as reappearance of CDAD within 4 weeks after symptoms had initially resolved."

      aloha,
      kamoa

    • "The objective of the study was to show that a 10-day course of OPT-80 was at least as efficacious (non-inferior) and safe as a 10-day course of Vancocin (vancomycin hydrochloride capsules, USP) for the treatment of CDI."

      I could not find the trial on the clinical trials website -- if you have the link please post it.

      The PR and Company tell us that the trial was designed (as a primary endpoint) for non-inferior. When going against a gold-standard often an intelligent thing to do.

      I disagree with your presumption that, while opt-80 beat vancocin pretty soundly in the area of occurrence in mild cases, that won't be the case in serious cases.

      • 1 Reply to EJ244
      • here they are EJ244

        phase II
        http://clinicaltrials.gov/ct2/show/NCT00097422?term=clostridium+difficile&rank=20

        phase III completed...
        http://clinicaltrials.gov/ct2/show/NCT00314951?term=clostridium+difficile&rank=16

        phase III ongoing...
        http://clinicaltrials.gov/ct2/show/NCT00468728?term=clostridium+difficile&rank=15

        look at all their exclusion criteria...
        severe and life threatening case of CDAD...

        did some searching to find out why...
        and came out with some ideas...
        - comparing it to vancocin (as you point out the gold standard) at the mild level is a low barrier to entry...
        there was no sense in comparing it to flagyl it is not the gold standard...

        i saw the safety/pharmacokinetic profile of the drug... when given intravaneously to 10 rats 5 died and 1 showed labored breathing... it states..."OPT-80 (dissolved in 10% dimethyl acetamide, 20% ethanol, and 70% PEG 400)
        caused acute mortality in rats at intravenous dose levels of ³ 200 mg/kg; it may also
        produce some acute toxicity at lower intravenous dose levels. Intravenous doses
        below 20 mg/kg have not been tested, and subacute and tissue effects have not been
        determined for intravenous dosing."

        the oral dose did not do this kind of adverse event... this is telling me that opt-80 is bad when absorbed by the body or a rat anyway, but not while in the gut because of its poor solubility...

        the severe case and life threatening cases of CDAD are patients with guts that are badly 'eaten up' by the BI strain or super toxic bacteria... it is contended that because of this it presents a way for a drug to readily enter the body... which begs the question does opt-80 do any harm to the patient when it enters the body through the gut of a severe or a life threatened cdad patient?...

        Is this why they chose not to include them in the opt-80 trials?...

        it is interesting to note that Genzyme (tolevamer) did a comparison with the severe cdad population against vancocin... they failed miserably.
        all imho....

        ditto with your disclaimer... like you i'm no doctor... my opinions are for entertainment purposes only... it shoulld not be taken as an advise... etc.. etc...

        aloha,
        kamoa

 
OPTR
12.780.00(0.00%)Oct 23 4:00 PMEDT

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