By: Adam Feuerstein | 08/21/14 - 10:23 AM EDTAmpio Pharmaceuticals (AMPE) is blaming a mini Polar Vortex for blowing up a pivotal study of its osteoarthritis drug Ampion.
Pivotal clinical trial drug specifications dictate precise temperature and handling conditions for all study drug product in order to assure that the conclusions about the safety and effectiveness of the tested drugs will be accurate and repeatable during routine clinical use. During the review of all documentation following the unblinding of the Study, our CRO determined that there were multiple instances where the in-package temperature monitor fell significantly below the 15 degrees C minimum required.
Although our entire trial drug supply was housed, packaged, and shipped in early January by a specialized drug shipment vendor contractually obligated to maintain pre-determined temperature requirements under all conditions, our CRO discovered much of the drug product received at the clinical sites had been below the temperature requirement and may have been frozen for some period of time. The drug temperature specifications were set because Ampion may lose potency if it is exposed to temperatures approaching freezing. We have contacted the FDA who has agreed to analyze the STEP trial as supportive data for our BLA.
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