Tris announces FDA approval of first-ever ER chewable tablet

Tris Pharma, Inc. ("Tris") is pleased to announce that the U.S. Food and Drug Administration ("FDA") approved the first-ever extended-release (ER) chewable tablet, capping off a highly productive year with three Tris-developed NDAs approved in a calendar year.

Prior to Tris' breakthrough ER chewable technology, extended-release tablets and capsules typically carried a warning, "should not be chewed or crushed." With other controlled-release dosage forms, chewing or crushing can cause dose dumping which can greatly increase the concentration of a drug in the body and thereby produce adverse effects or even drug-induced toxicity. In clinical studies, Tris has demonstrated its extended-release chewable tablet technology releases drug consistently whether it is chewed or swallowed whole. This patent-protected technology offers patients convenience, flexibility and confidence.

ER chewable tablets are an extension of Tris' LiquiXR® platform, a particulate based technology where hundreds of millions of tiny (about 100 microns) particles deliver drug over time. The extended release is facilitated by an extremely robust and flexible particle coating, which is why chewing does not compromise the release profile. The same particles can be used to formulate various oral extended-release dosage forms such as liquid suspensions, dispersible tablets, film strips, and ODT's. Further, Tris' ER chewable technology can be scored just like any immediate-release tablet.

"Tris has a solid track record of breaking new ground within the drug delivery technology space including the first ever 24-hour extended-release oral liquid and now the first ever extended-release chewable tablet," said Ketan Mehta, Tris' founder and CEO. "The 2015 calendar year has been a highly productive year with three NDA approvals, all on their PDUFA dates, bringing a total of seven NDA approvals in the past six years. This would be an incredible accomplishment for any large company but is unheard of for a company of only 400 employees. This speaks well of our combined R&D and Technical Service, Regulatory, and Medical teams. They have been outstanding all year in delivering great results."