New PAZ320 Diabetes Medication May Get Approval From FDA Soon

A $1.3-million company is continuing with its lengthy process of developing its diabetes medication through a safer route, a medical expert noted, citing published reports, while a $36 billion company is defending its Byetta diabetes medicine from claims of complications.  Called the PAZ320, this new medication has already undergone tests for its safety and efficacy with very promising results. At this point in the product development, it is being tested for adverse reactions considered very critical in light of the recent controversy linking Byetta to adverse complications such pancreatic cancer as suggested in a BMJ report.

 

Designed to reduce the elevation of post-prandial glucose (PPG) or the after-meal blood sugar, the PAZ320 is a single-structure, non-systemic, chewable carbohydrate hydrolyzing enzyme inhibitor (CHEI). To be taken before meals, this chewable tablet works on the gastrointestinal tract to block the action of carbohydrate-hydrolyzing enzymes that break down the carbohydrates in foods during digestion, thereby lowering the amount of available glucose absorbed via the intestine. The action caused by this medication makes it ideal for the prevention or delay of type 2 diabetes and its long-term damages such as heart disease, stroke, nerve damage, kidney diseases and other serious conditions.

 

The makers of PAZ320 has already requested the Food and Drug Administration (FDA) for an Investigational New Drug (IND) application meeting after completing phase II which consisted of initial clinical trials to test the product for its safety and efficacy. To ensure that this medication will not only be effective but also safe to be used for the millions of people suffering from diabetes and those who may be candidates of developing this disease, further testing will be undertaken by the company.

 

Significant improvements on the patients were noted and that no serious adverse reactions were observed after the analysis of its clinical trial which involved 24 patients diagnosed with type 2 diabetes. The clinical study consisted of adults between the ages of 18 to 75 with body mass index of 25 to 45 kg/m2. All 24 subjects were diagnosed with type 2 diabetes with an average blood glucose level of 9 percent and were presently on insulin or oral agents for their existing conditions. A reduction of post-meal glucose in the blood by 40 percent was reported by 45 percent of the respondents. It was also revealed in the trial that the PAZ320 does not correlate with duration of the diabetes and that it works regardless of the present medications used by the patients.

 

The New Hampshire-based Boston Therapeutic, the company behind the PAZ320 has been in operation for only around three years making it a relatively new player in the industry. Since its start as a newly incorporated company in 2010, it has only been able to market one product with the PAZ320 expected to be its second offering. Its patience in the development of this product, even while incurring losses for the past years, may speak well for the company’s commitment to bring safe and effective products to the millions of diabetes-stricken people around the world.

 

References:

i-newswire.com/as-big-pharma-deals-with-diabetes

bostonti.com/product-pipeline/

marketwire.com/press-release/boston-therapeutics-requests-ind-meeting-with-fda-paz320-reduce-postprandial-hyperglycemia

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