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German biopharmaceutical firm Paion has revealed that extensive meta-analysis and PK/PD modeling on the basis of data from past trials with the drug morphine-6-glucuronide (M6G) demonstrated the desired reduction in side-effects compared to equi-analgesic doses of morphine. They expect that the results of the analyses will substantially improve the likelihood of success for the development of M6G.
Paion is now re-launching the partnering process for M6G following a phase II and two phase III studies that demonstrated the drug’s ability to reduce pain as effectively as morphine – which is the current standard treatment for post-operative pain.
The studies also showed a significant reduction in vomiting and nausea, both common side effects of morphine.
M6G was added to Paion’s portfolio with the acquisition of CeNeS in June this year. Following the transaction, Paion initiated a meta-analysis of the clinical data in order to re-evaluate the study results obtained so far, and to gain a clearer view of the status of the M6G programme.
Modelling analyses have also been conducted to simulate dose-response relationships and pharmacodynamic effects. The results support the product profile of M6G, both in terms of its analgesic properties and side-effect profile, and in reproduce the previously observed longer duration of action of M6G compared with morphine.
Paion believes that, based on this model, even at increased doses M6G may be better tolerated than equivalent analgesic doses of morphine.
Copyright PA Business 2008