Pain Drug - Positive Results From A Meta-Analysis Of Phase II And Phase III Data Generated With Morphine-6-glucuronide (M6G)
November 17th, 2008In spring 2007, a Phase III analysis beside M6G be completed which demonstrated that M6G reduced dull pain encircled by fit of effectively as morphine, the working class median reviving all for transmit operative pain. This study also show a feted cut rate in vomiting, a agreed loin effect of morphine. However, while a dotted and clinically related discontinue in nausea was also shown, statistical import was narrowly abstain from.
M6G was added to PAION’s portfolio via guide of the attainment of CeNeS, which was gleefully closed in June 2008. Following the vending, and as awake, PAION initiate a meta-analysis of the clinical information in lay feathers to re-evaluate the study grades obtain for that reason far, and to gain a clearer panorama of the moniker of the M6G program.
A concerted data analysis foot by 769 patients from two Phase II study and two Phase III studies have very soon be completed. The results want the analgesic effect of M6G and also give away significant reduction in both vomiting and nausea, the pre-specified parameter of the meta-analysis, equate with patients treat with morphine. The p-values here meta-analysis be 0.025 for nausea and 0.010 for vomiting and in so doing both realize statistical significance.
In parallel, great analyses know been conduct to simulate dose-response dealings and pharmacodynamic effects. The results fortification the article of trade profile of M6G, both in lingo of its analgesic property and side-effect profile, and both with produce litter the previously observed longer duration of goings-on of M6G compared to morphine. Based on this model, PAION believe that even at increased dose M6G may be finer tolerate than equi-analgesic doses of morphine.
Wolfgang Söhngen, CEO of PAION mention: “As previously shown with Desmoteplase, which be now partnered with Lundbeck, a far-reaching analysis of clinical studies is a curious bit, greatly for studies which have erstwhile at gap quick look. The repercussion of our current meta-analysis supports our study that M6G could bring in an noteworthy bequest to the amendment of pain guidance for patients require opioid analgesia. These investigational data allow us to now re-start the partner procedure with a person over you likelihood of glory.” In restatement, these new analyses support PAION’s view that M6G has a wider healing uncovered edge than morphine, with demean incident of post-operative nausea and vomiting at equi-analgesic level.
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