Buccal drug delivery pioneer, Generex, is expanding its diabetes treatment pipeline to include a new metformin chewing gum that aims to avoid the significant adverse gastrointestinal side-effects often accompanying the use of metformin tablets.
>Generex, who recently launched the world's first non-injectable insulin in the form of an oral insulin spray, is now developing a form of metformin that can be chewed, thereby delivering metformin into the human body by way of the buccal cavity (the mouth).
This new method of drug delivery may provide relief for the approximately 30 per cent of metformin users who develop significant adverse gastrointestinal effects from taking metformin tablets, including diarrhea and nausea/vomiting.
Metformin is used with or without insulin for the treatment of Type-2 diabetes and is also used to prevent the development of diabetes in people at risk, as well as treating polycystic ovary syndrome (PCOS), and non-alcoholic steatohepatitis (liver disease).
Metformin single drug formulations record sales of over $2.2 bn (€1.8 bn) and over 30.5 m prescriptions in the US each year.
A recent small clinical trial with Generex's metformin gum showed that it displayed a pharmacokinetic profile similar to that of the currently available metformin tablets and therefore shows promise as an alternative method of delivering metformin.
However, this study only involved ten people and much larger and more structured clinical trials will need to be conducted before there is any conclusive evidence of its effectiveness and benefits.