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October 04. 2012 8:13PM
Chewable tablet for diabetes a step closer to FDA approval
MANCHESTER — Boston Therapeutics, a pharmaceutical research and development firm, is one step closer to FDA approval for a chewable version of a widely used generic to treat diabetic or pre-diabetic patients.
The company announced Thursday that the FDA has authorized an abbreviated new drug application, which means no further clinical trials are needed to demonstrate the safety or effectiveness of the product.
Boston Therapeutics intends to market the new formulation of the generic drug metformin hydrochloride under the brand name Pazamet. Metformin is already marketed in tablet Bristol-Myers-Squibb.
“The difference is that Pazamet is a chewable tablet, which makes it much more palatable for children or older people who might have esophagus issues,” said Anthony Squeglia, head of investor relations at the company headquarters on Elm Street in the Brady Sullivan tower.
The next step before moving on to final approval, Squeglia said, will be bio-equivalency studies in which the company will have to prove its product is at least as good as generic metformin, one of the most widely prescribed diabetes drugs in the world. Pharmacies in the U.S. alone filled 50 million prescriptions for the drug in one form or another in 2010.
The drug helps people with diabetes or pre-diabetic conditions manage their blood sugar.
A publicly traded company registered with the SEC, Boston Therapeutics specializes in diabetic therapies, and has already developed a widely used product called Sugardown, which works in the gastrointestinal tract to slow down the digestion of carbohydrates and the release of glucose.
Squeglia said the company hopes to have Pazamet on the market by 2013. While only four employees staff the research and development office on Elm Street in Manchester, Squeglia said, “We plan to be much bigger.”
The company uses a contract manufacturer to produce the drugs, once they receive FDA approval.
While Squeglia wouldn't identify the name or location of that manufacturer, he said it was a New Hampshire-based company and that approval of Pazamet would likely create new jobs at the manufacturing site.
The company also has an office in Texas and Ontario, Canada, and sales representatives throughout North America.
dsolomon@unionleader.com
The company announced Thursday that the FDA has authorized an abbreviated new drug application, which means no further clinical trials are needed to demonstrate the safety or effectiveness of the product.
Boston Therapeutics intends to market the new formulation of the generic drug metformin hydrochloride under the brand name Pazamet. Metformin is already marketed in tablet Bristol-Myers-Squibb.
“The difference is that Pazamet is a chewable tablet, which makes it much more palatable for children or older people who might have esophagus issues,” said Anthony Squeglia, head of investor relations at the company headquarters on Elm Street in the Brady Sullivan tower.
The next step before moving on to final approval, Squeglia said, will be bio-equivalency studies in which the company will have to prove its product is at least as good as generic metformin, one of the most widely prescribed diabetes drugs in the world. Pharmacies in the U.S. alone filled 50 million prescriptions for the drug in one form or another in 2010.
The drug helps people with diabetes or pre-diabetic conditions manage their blood sugar.
A publicly traded company registered with the SEC, Boston Therapeutics specializes in diabetic therapies, and has already developed a widely used product called Sugardown, which works in the gastrointestinal tract to slow down the digestion of carbohydrates and the release of glucose.
Squeglia said the company hopes to have Pazamet on the market by 2013. While only four employees staff the research and development office on Elm Street in Manchester, Squeglia said, “We plan to be much bigger.”
The company uses a contract manufacturer to produce the drugs, once they receive FDA approval.
While Squeglia wouldn't identify the name or location of that manufacturer, he said it was a New Hampshire-based company and that approval of Pazamet would likely create new jobs at the manufacturing site.
The company also has an office in Texas and Ontario, Canada, and sales representatives throughout North America.
dsolomon@unionleader.com
