Extended release desvenlafaxine is currently being marketed in regulatory markets of EU and USA in the form of succinate salt. Client was proposing to market the same molecule with change in salt form i.e. oxalate in Australian market due to patent issue. This molecule is considered as a new chemical entity by TGA which poses a new challenge for conducting bioequivalence study for Desvenlafaxine oxalate. No relevant clinical data was available in public domain to support the application for bioequivalence study to ethics committee and regulatory agency.
Based on toxicity data collected on oxalate salt in the animal studies, literature references for availability of the oxalate in humans in endogenous form and from oral consumption of vegetables, juices etc and correlating the same in comparison to patients, a safety report was prepared by our medical expert team and submitted to ethics committee and regulatory agency along with the application.
Australian regulatory authority required clinical trial as this been a new drug application.
Based on scientific rationale and toxicologist expert opinion, we justified that there is no need to conduct clinical trial. Our expert report concluded that high dose of oxalate salt will not have any toxic effects to the healthy volunteers.
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