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Tris Pharma Announces Acceptance of Its First Two NDAs
Date:5/13/2009

- First ever 24 hour oral liquid sustained release formulation submitted to the FDA

- Validates OralXR(TM) technology platform - eliminates the need to swallow pills by providing sustained release in liquids, chewable tablets, and films

- Upon approval will provide both liquid and tablet forms as alternative to current twice-a-day immediate release tablet

SOUTH BRUNSWICK, N.J., May 13 /PRNewswire/ -- 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 "
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SOURCE Tris Pharma
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