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Optimer Pharmaceuticals, Inc. (OPTR) Message Board

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  • max51005 max51005 Mar 11, 2011 10:08 AM Flag

    Just a guess, but....

    Does anyone know about pricing of Fida? I've heard about $150/dose? And with a treatment being 5day twice a day = $1,500.

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    • ine2pharma,

      Very good points. Publication in NEJM and design of study approved by FDA is no guarantee of approval.

      Looking at the data on Xifaxan, Salix pharmaceuticals however, 11 patients of irritable bowel needed to be treated for one to benefit which I thought was not too robust when I read the study, which interestingly happens to be exactly similar to HGSI drug approval of BENLYSTA by the FDA. Bentlysta treated patients also had a higher risk of infections and death compared to placebo, yet was approved. Interestingly HGSA is only up less than 10 % since the FDA approval (jump of about 13% and down today 3.75%).

      So no one can really predict how FDA will act, but I think the data on fidaxoxamin looks very good

      • 1 Reply to anitdua
      • Jeepers, whoever said that FDA looks at each application in isolation is correct...Each application is viewed independently and judged on their own merits and in their own context. The only half-decent comparison lately has been the obesity drugs that marched through the process last Fall/Winter. Same indication, same patient population, probably the same FDA reviewers, etc.

        But. you can't even compare two antibiotics and have an idea what the FDA will do. The Salix product was designed to be used in the general ambulatory population for IBS, amongst lots of ambulatory IBS patients, potentially. And the issue they had, if I remember (geesh, it's only been a week or so!) is that they wanted some additional data. I was trying to figure out if they had this data already and needed to get it out of the existing clinical trial datasets - or do they have to run a whole 'nother trial to get whatever it wass FDA wanted. It's a shame that FDA can approve a trial design and then say "Oh yeah, what about relapses?" (or whatever)" during the review process. I am sure the execs at Salix are like "Are you kidding me??!"

        OPTR's antibiotic, on the other hand, will not be in the hands of tons of patients for long periods of time. It should be an "institutional" drug, used primarily in hospitals, maybe nursing homes and for a short (relatively) treatment periods. It's potential to be harmful when over-used is nil.

        By the way, if you don't think an IBS drug and perhaps IBS can kill ya, ask GSK about Lotronex. Even though Lotronex may have been clean, the agency wasn't as sure - and asked GSK to pull it. There were just a handful of ischemic colitis patients ending in death that killed it. And there were a lot of patients clammoring for it - but FDA is safety conscious to the hilt lately.

        Back to my original response to this thread - you cannot compare or evaluate two totally different disease states and drugs and predict what the agency will do. They are all independent decisions based upon the quality of the indiviudal submissions. It's not even apples and oranges.

        All that said, I haven't seen a more robust set of data for safety and efficacy in a submission in s long time - so I think we have a winner here. My question is will it be unanimous at the adcom mtg. Whenever I think that, there's some hidden piece of information that bites me! So - take my word at your own risk! Good luck to all longs!

    • I heard a course of Vanco costs $1500 from someone who had to pay for it. Don't know if that was for 10 or 14 days of treatment.

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