Tris Pharma Announces Acceptance Of Its First Two NDAs

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 14 May 2009 - 1:00 PDT

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Tris Pharma, a privately owned specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has accepted its first two New Drug Applications (NDAs) for once-daily formulations of a cardiovascular drug. If approved, Tris Pharma's liquid and solid dosages will provide an alternative to the currently available immediate release, twice-a-day tablet.

LiquiXR(TM) is the liquid dosage form of the company's proprietary OralXR platform. Only two extended release liquid pharmaceuticals exist today. If FDA approves Tris' liquid formulation, it will be the first sustained release liquid commercialized in more than 25 years and the first-ever liquid dosage form available in a 24-hour extended release formulation.

"LiquiXR offers the compliance and convenience benefits of other controlled release dosage forms and allows physicians a limitless number of dose options since the dose can be customized through titration," says Dr. Yu-Hsing Tu, Tris' Head of R&D. "This will be particularly valuable as the technology is leveraged in the development of CNS, pain, and other narrow therapeutic window compounds."

The company's OralXR platform also includes other dosage forms such as ODT, chewable tablets, and film strips. Using these technologies, Tris Pharma is developing products that are targeted toward pediatric and geriatric populations and other patients who have trouble swallowing a traditional "pill."

"FDA's acceptance of our two NDAs validates Tris' OralXR platform, and is an important milestone for the company," says Tris Pharma CEO and Founder Ketan Mehta. "We have an exciting future, with a robust pipeline of more than 20 extended release products in different therapeutic categories currently in development."

Tris' drug delivery technology also offers other improvements over those used for the older products. To manufacture the cardiovascular drug, the company uses a safe water-based process, replacing the need for the toxic organic solvents used in the older products. This new aqueous solvent, coupled with Tris' patent-pending manufacturing process, also improves product stability and batch-to-batch uniformity.

About Tris Pharma:

Tris Pharma is a privately owned, product-focused, specialty pharmaceutical company engaged in the research and development of innovative drug delivery technologies. Through its OralXR platform, Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms where by patients do not have to swallow a pill. Tris' Nobuse platform provides abuse-deterrence for opioids and other abuse-prone drugs. The company has more than 30 Rx and OTC products in development with pharmaceutical partners. Tris' R&D and manufacturing facilities are located in Monmouth Junction, New Jersey.

Source: Tris Pharma