FDA approves first chewable extended-release tablet, creating new drug delivery partnership opportunity

Chewable XR--Courtesy of Tris Pharma

Chewing extended-release medications is typically dangerous because it can cause "dose dumping," resulting in excessive concentrations of the drug in the body, or even toxicity.

Monmouth Junction, NJ's Tris Pharma overcame these challenges, earning the first-ever FDA approval for a chewable extended-release tablet. The company said it proved the tablet, dubbed ChewableXR, can release drugs consistently whether swallowed or chewed. The milestone enables the company to market the tablets as a platform technology to third-party partners; it is not intended to treat any specific therapeutic area.

ChewableXR is the company's fourth drug delivery offering under its OralXR controlled release technology. Delivery occurs via millions of small (about 100 microns) particles that coat the drug. Tris Pharma says they are highly flexible and durable, enabling them to withstand the rigors of chewing.

The drug can be released over a period of up to 24 hours because the coating protects the drug, limiting bodily absorption until the active ingredient reaches the stomach. In addition, according to the company's website, the coating of microparticles particles provides taste-masking, and excipients can be added to improve taste.

It's not difficult to imagine the applications of ChewableXR toward pediatric medications. Elderly patients sometimes have difficulty swallowing as well.

"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, the CEO of the 400-person company. "The 2015 calendar year has been a highly productive year with three NDA approvals, all on their PDUFA dates, bringing a total of 7 NDA approvals in the past 6 years."

The wait for the first pharma player to deploy ChewableXR begins. Tris Pharma lists several partners on its website related to its other drug delivery platforms, including Pfizer ($PFE), Actavis, Perrigo ($PRGO) and Vernalis.

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