Adolor Opioid IND Delayed At Least Six Months
This article was originally published in The Pink Sheet Daily
Executive Summary
Product is on clinical hold following FDA's request for additional preclinical safety studies.
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Adolor IND (correction)
Potential convulsant activity is an issue for the Delta opioid receptor class, but FDA has not asked Adolor to examine the potential activity as part of its clinical hold on the IND of the firm's compound ADL5859. In a Jan. 30 1article, "The Pink Sheet" DAILY incorrectly reported that FDA had asked for information on that as part of the clinical hold
Adolor IND (correction)
Potential convulsant activity is an issue for the Delta opioid receptor class, but FDA has not asked Adolor to examine the potential activity as part of its clinical hold on the IND of the firm's compound ADL5859. In a Jan. 30 1article, "The Pink Sheet" DAILY incorrectly reported that FDA had asked for information on that as part of the clinical hold
Adolor's Entereg "Approvable"; Ongoing Study May Provide Confirmatory Data
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