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Progenics Pharmaceuticals, Inc. Message Board

  • dcxavier dcxavier Jun 4, 2011 5:52 PM Flag

    AZN setting high bar for oral OIC drug

    Look at the scope of the Phase III's for NKTR-118. Either AZN is going way overboard, or there may be more needed than the single ongoing Phase III for oral Relistor.

    http://clinicaltrials.gov/ct2/results?term=nktr-118

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    • I told you SLXP was cutting corners.

    • play_4_less,

      Right on the mark with your post. Good job. From the last CC I listened to, PGNX will get about 60% of the rights to Relistor if a deal is made to sell Relistor in Europe, It sure looks like Mark Baker made a great deal for PGNX with Salix.

    • You had this major CONCERN half year ago, and still you have not listened to PGNX CC once in the past half year. And here is what you don't want to know:
      ------------------------------------------------------------------
      FDA TOLD SLXP that there is no need for one year oral methylnaltrexone safety trial as long as oral methylnaltrexone effecacy and safety are comparable subcutaneous methylnaltrexone.
      ------------------------------------------------------------------

      The news release yesterday included the statement below:
      ----------------------------------------------------------------
      Overall, efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic, non-cancer pain. The overall observed safety profile seen in patients treated with oral methylnaltrexone was comparable to placebo in this study.
      ----------------------------------------------------------------

      Again SLPX had done their DD before it made decision to be involved with methylnaltrexone; that is why there should not be supprise to see methylnaltrexone chronic indication to be approved for both oral and subcutaneous.

    • As expected, oral Relistor is effective and I fully expect it to meet safety endpoints. But it's going to boil down to whether the FDA will accept the abbreviated SLXP safety study.

    • dcxavier,

      What are you talking about?

      <The metabolic path is different.>

      The point is the oral and SC formulation get into the bloodstream and neither crosses the blood brain barrier. Are you saying Relistor is broken down into different end products when they are given in the SC formulation and the oral formulation? You really don't have any idea, do you?

      <The Entereg results were highly unexpected to say the least, and the cause was never pinned down. They were able to get Entereg approved by putting strict limitations on its use.>

      Right, Entereg is a very different drug than Relistor, and Entereg showed unexpected safety issues that limited its usage. Relistor has never shown any such health issues, but was PGNX was forced to run a one-year safety study because of Entereg data. Relistor has already completed a one year safety study and Salix saw the data before making their agreement with PGNX. In case you haven't noticed, SALIX/PGNX used that study as the basis for their submission into the chronic pain area.

      <Just saying, it wouldn't be a shocker for the FDA to request the data for oral Relistor. It actually surprises me a bit that Salix is proceeding with a short study without a SPA in place.>

      It would be truly stunning for the FDA to ask for another one year safety study on a compound that already went through a one-year safety study simply because it went from an SC to an oral formulation. There would have to be indications that the drug is broken down, not simply because the route is different.

    • The metabolic path is different. The Entereg results were highly unexpected to say the least, and the cause was never pinned down. They were able to get Entereg approved by putting strict limitations on its use.

      Just saying, it wouldn't be a shocker for the FDA to request the data for oral Relistor. It actually surprises me a bit that Salix is proceeding with a short study without a SPA in place.

    • dcxavier,

      PGNX has already COMPLETED the one year safety study for Relistor using their SC formulation. They will not need another one for the oral formulation.

    • I would be surprised if the FDA approves oral Relistor without a one year safety study. A one year safety study is part of the NKTR-118 plan.

      ********

      Entereg - A mu-opioid receptor antagonist, approved for *15 day hospital use only*.

      "There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients being treated with opioids for chronic pain."

      http://www.drugs.com/newdrugs/adolor-glaxosmithkline-announce-fda-approval-entereg-alvimopan-management-postoperative-ileus-poi-983.html

    • Not sure what price they will put on oral MNTX, but i known the subcue version is very expensive. Thus, i would hope that the oral version would be much cheaper since they do not have to package it with syringe etc etc.

      I question how effective the oral version will be relative to the subcue version due to route taken, but i assume the dose for oral will be increased to reach the same effectiveness as subcue version. regards

    • http://clinicaltrials.gov/ct2/results?term=nktr-118

      I'm bumping this. More studies added, including a twelve week extension. The extension is important data for a drug intended to be taken daily for a chronic condition.

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