Generex Biotechnology produces Metformin chewing gum product for forthcoming clinical study
US-based Generex Biotechnology Corporation, a leader in drug delivery for metabolic diseases through the inner lining of the mouth, has produced clinical samples of MetControl, its proprietary Metformin chewing gum product.
US-based Generex Biotechnology Corporation, a leader in drug delivery for metabolic diseases through the inner lining of the mouth, has produced clinical samples of MetControl, its proprietary Metformin chewing gum product.
The samples were manufactured under GMP conditions and will be used in a forthcoming trial, the results from which will allow the company to proceed with additional r&d initiatives and consider regulatory agency registration applications.
The protocol for the MetControl study is an open-label crossover study comparing MetControl and immediate release tablets in healthy volunteers. Approximately 36 patients are expected to participate in the study.
Metformin is a generic drug 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, but there are still millions who do not use it because of a variety of factors, including gastrointestinal side effects, large pill size and bitter taste (especially in the growing population of children with Type 2 diabetes).
The delivery of Metformin in a good tasting chewing gum format may make the drug more acceptable to these patients and may thereby increase compliance.
"We are pleased to have completed this significant milestone with respect to our medicinal chewing gum product," said Rose Perri, the company's chief operating officer. "This represents the expansion of the company's proprietary drug delivery platform as it utilises the core science behind its RapidMist delivery system in another form and application."