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Optimer Pharmaceuticals, AŞ Message Board

  • kamoa_1 kamoa_1 Mar 31, 2011 10:39 PM Flag

    FDA in a quandary...

    How can they approve Fida, that OPTR claims not soluble, no systemic absorption therefore no adverse events, and deny VPHM's same claim about their drug Vanco?

    The simple logical answer would be.. They can't. They'd appear capriciously partial...

    To be fair...
    The FDA will have to expose Fida to the same or more rigorous and stringent tests as they are doing to Vanco...

    Especially Fida appears to be more toxic than Vanco..
    -Fida kill's 2.2 lbs. rats at 200 mg IV(LD50)...
    -Vancomycin can be administered through IV (500mg every 6 hours)...

    But like the man said the FDA is the FDA...
    all imho.


    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • The shorts are running for cover!

    • ooops!

      forgot to say aloha to my other friend...
      lataz mackie!... nice to hear you made dough....AGAIN!


    • sweet! dude!...
      and I could tell you I was secretly going long on OPTR...
      APRIL fool!...

      but yeah bro I also got some board i could lend you...
      if you want new ones... i have friends at surf shops..
      i could hook you up with'em....

      gotta run!... surf's up!!


    • where are u today? sweatin' it out over at VPHM board?

    • gortsemad Apr 1, 2011 9:57 AM Flag

      vanco is often given iv, and thus very much absorbed- not sure what you are talking about

      • 1 Reply to gortsemad
      • Vancomycin, yes, Vancocin, no. That's the difference between the two. Vancocin is a formulation of vancomycin that is ingested orally and isn't released until it reaches the area where c diff resides. The complexity in creating this formulation is the reason the compound has been able to survive without patent protection and generic competition as long as it has.

    • No signnificant difference in side effects between Fida and Van.

      Data has been presented to show that Fida plasma level is < 50 ng/ml in over 90% of patients, which is pretty minimal.

      Unchanged drug (and principal metabolite) levels are way above mics which is also showing poor binding to protein in fecal matter.

      Don't have total ADME data which would have been interesting but the overall evidence is compelling and incontrovertible that Fida casues no greater harm than Van but has distinctly/significantly greater benefit on recurrence.

      • 2 Replies to pashidev
      • Does it look like absorption to you Ms. Pashidev?
        What level is safe?

        "Plasma levels of fidaxomicin and its metabolite OP-1118 were higher in subjects in phase 3 trials than in healthy volunteers. Phase 3 trial subjects had levels of fidaxomicin and OP-1118 up to 237 ng/mL and 871 ng/mL, respectively whereas no healthy volunteers receiving fidaxomicin had fidaxomicin or OP-1118 plasma levels above 50 ng/mL Plasma fidaxomicin levels were approximately 2 times higher in older (≥65 years) subjects than younger (<65 years) subjects."


      • RECURRENCE is the major issue with c-diff, not only due to patient suffering and possible death but also due to the significant RECURRING COSTS OF TREATMENT from multiple hospitalizations. Optimer is presenting in fida an opportunity for the FDA to address the ever-increasing cost of acute care in the U.S. health system relating to hospital readmissions for c-diff (if you don't think it's an issue, why is CMS clamoring to reduce the % of re-hospitalizations for the same diagnoses and punishing hospitals who treat patients repeatedly for the same illnesses?), with minimal barriers to it's prescription and use. Too bad the company does not also have solutions for recurrent pneumonia, CHF, COPD exacerbation, etc...but, maybe another company does. All imo, of course, and please conduct your own DD prior to investing in stocks.

    • apparently kamoa did not like the rebound from lows OPTR experienced today...if he would just bail on VPHM and come to where the grass will be greener in May, he'd - imo, of course - be better off. kamoa, stop bashing fida to make vanco look better than it really is...generic competition, multiple dosing in excess of that required with fida, higher recurrence rates for c-diff than're fighting an uphill battle, my friend...imo. good luck, tho. fida is the future of c-diff treatment, and sometimes the truth hurts.