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Latest Type 2 Issues Articles
Glucose-controlling metformin, the generic drug that is the first medication for many newly diagnosed type 2s, could soon be available in a chewing gum.
That’s the hope held by Massachusetts-based Generex Biotechnology Corporation, which has announced that it is ready to test its proprietary metformin chewing gum product, MetControl™, on 36 volunteer patients. In the study, Generex will compare the speed and efficacy of MetControl to that of immediate-release metformin tablets.
Metformin is the most prescribed drug for type 2 patients. Nevertheless, many people with diabetes avoid using it because of its gastrointestinal side effects, large pill size and bitter taste. These factors are especially off-putting to the increasing number of children being diagnosed with type 2.
Generex believes that the delivery of metformin in a good-tasting chewing gum will make the drug more acceptable to these patients and thereby increase adherence with diabetes therapy.
Because metformin is safe, well known and well established, the company does not anticipate taking as long to come to market with MetControl as it would with a product containing a new active compound. Such products typically must undergo stringent testing that can last years.
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Bad option! When it comes controlling diabetes it has to be a personal decision and auto discipline instead of looking for “better way” to avoid my duty.
This is an exciting approach that should help bring more Type 2 patients in compliance with their metformin regimen. I have followed Generex for years, and it was in Jan 2006 that they relased their first positive results for Metcontrol Gum.
I know that they are now partnered with medicinal gum leader Fertin Pharma for the Type 2 gum's development and that the gum was designed to offer a 214.5 mg per piece dose control. Generex, based in Toronto, has stated that the gum will be the size of a chicklet and be available in numerous flavors to mask the bitter metformin taste.
Generex has patented their Rapidmist buccal delivery enhancers that enable the absorbtion of drugs to take place in the buccal cavity (i.e. the inner lining of the mouth.) That should be a big advantage for absorbtion of metformin, since Metcontrol Gum would avoid the significant adverse gastrointestinal side-effects that often accompany the swallowing of the dreaded, yet effective, metformin tablets. With the recent news of cardio risks associated with other oral Type 2 pills (i.e. Avandia), metformin tablets have seen a rise in prescriptions as this generic drug is proven in terms of efficacy and safety.
If Generex is successful in following the Abbreviated Drug Submission approval pathway of Health canada and the FDA, we may see metcontrol Gum approved for marketing and sale after this next small study. The FDA website stated that Abbreviated Drug Submissions require establishing "bioequivalence" to a referance drug (metformin tablets) in 24 to 36 healthy, volunteers. And that is exactly what Generex upcoming Metcontrol Gum is designed to prove. The first trial of 10 healthy volunteers ended with these results, and now with Fertin Pharma's inclusion it is very reasonable to conclude a new paradigm of metformin delivery is a near term reality. For Type 2's, good health may never have tasted so good!
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