gmmm,
<Was doing a pubmed search on Relistor and some interesting articles on Opioid-Induced Constipation therapies came up (I'll have to look at them more) noticed too that Relistor (sub-q) is only approved for extremely ill patients does it have some tox issues or something?>
The restriction is because a competitor drug, Entereg from ADLR, had safety issues and was blocked by the FDA for approval except for short term surgical usage. However, the FDA ordered a one year safety study of Relistor because of Entereg's problems. That study has been completed, and PGNX will present the data in May, and will submit for label expansion into the chronic pain market in the 2nd quarter. The data must be good because Salix partnered Relistor with PGNX after seeing the data.
NKTR will have to perform a one year safety study if they want to enter the chronic pain market,. PGNX also has oral Relistor formulation in phase III.
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