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Progenics Pharmaceuticals, Inc. Message Board

  • typecheck typecheck Mar 15, 2013 11:48 AM Flag

    Salix will file application of Relistor for chronic pain in EU

    This is great news. Though the OIC market in EU is not as big, it is still significant revenue source.

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    • Subcu Relistor for chronic pain will be obsolete the moment an oral mu-opioid antagonist is approved. The CC also stated that another Phase III safety study will be required for oral Relistor. Wonder why that hasn't been started already. NKTR-118, CB-5945 and TD-1211 will all be running ahead of it.

      • 1 Reply to dcxavier
      • I think Subcu Relistor has its own unique advantage. Oral Relistor has very low bioavailability and slower action than Subcu Relistor. For patients in palliative care, oral drugs may not be viable either.

        In any case, all mu-opioid drugs are on hold right now. No one is getting pass FDA hurdle until the appeal from Salix is answered. They certainly can't start another trial that FDA asked for because that would be too expensive and too long to justify. Unless FDA changes its mind, we are not moving forward with Relistor OIC indication. Nor can any other competitors.

    • Interesting question by Achshoft and comment by PGNX where he asked about bioavailability in the bloodstream in sub-cut vs oral Relistor. The issue was that less Relistor is in the blood-stream via oral dosing and the issue was raised on how this might impact the FDA on the chronic pain usage, cardiac opiate withdrawal. Nothing certain but I thought it was interesting.

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