Generex announces positive results of Metformin chewing gum trial

Generex Biotechnology, the US-based specialist in drug delivery for metabolic diseases through the inner lining of the mouth, has reported results from a clinical trial of MetControlT, its proprietary Metformin chewing gum product.

The study has found that MetControl Metformin chewing gum and traditional Metformin tablets are bioequivalent in both the rate and extent of systemic absorption, which means they are therapeutically equivalent and therefore interchangeable.

The study is being conducted at West Houston Clinical Research Services in Houston, Texas.

Twenty-four healthy subjects were enrolled in the trial to evaluate the bioequivalence of 2 x 250mg MetControl compared with 500mg Metformin tablets. The subjects received one assigned treatment during the first period and the alternate treatment during the subsequent period. A seven-day washout was included between the dose administrations.

Bioequivalence was established with a power of 1 based on 90% confidence interval (CI). Preliminary data obtained from the study reveals that at a 90% CI, the area under the drug plasma concentration over time curve (AUC) and the average maximum Metformin plasma concentration (Cmax) were within the bioequivalence accepted range of 80-125%.

Upon final confirmation of statistical data, it is the company's intention to proceed with various submissions for regulatory approval of MetControlT as a generic Metformin product. The r&d path that leads to commercialisation of this product is not anticipated to be as lengthy as a typical new chemical entity (NCE) as Metformin itself is not a new active compound, the company said.

Metformin is used to regulate blood glucose levels by reducing liver glucose production and improving the insulin sensitivity of cells. It is the backbone of almost all treatments for Type 2 diabetes mellitus. Despite the fact that it is often prescribed for Type 2 diabetes, millions do not use it because of gastrointestinal side effects, large pill size and bitter taste.

The company said the delivery of Metformin in a pleasant-tasting chewing gum format might make it more acceptable to patients and increase compliance.

"These results are very encouraging," said Anna Gluskin, Generex's president and chief executive. "We look forward to proceeding with the regulatory path to product commercialisation. MetControl will be a complimentary product to Generex Oral-lynT, our proprietary oral insulin spray product."