Navigation Links
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 "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. For more information visit http://www.trispharma.com


'/>"/>
SOURCE Tris Pharma
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Addrenex Pharmaceuticals Expands Product Pipeline by Licensing New Drug to Treat Narcolepsy
2. BioCryst Pharmaceuticals to Announce Peramivir Update and First Quarter 2009 Financial Results on May 8, 2009
3. ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting
4. FDA Approves Vanda Pharmaceuticals Fanapt(TM) for the Treatment of Schizophrenia
5. Paloma Pharmaceuticals Presents at the Association for Research in Vision and Ophthalmology 2009 Meeting
6. Poniard Pharmaceuticals Reports First Quarter 2009 Financial Results and Provides a Corporate Update
7. Transcept Pharmaceuticals to Report First Quarter 2009 Results
8. Oramed Pharmaceuticals Announces Launch of Phase 2B Clinical Trials in South Africa of its Oral Insulin Capsule
9. Pharmateks Highly-Potent and Cytotoxic (HP/C) Facility Positions It as Industry Leader in Development and Manufacturing of HP/C Compounds
10. Potentia Pharmaceuticals POT-4 Drug Candidate for Age-Related Macular Degeneration Successfully Completes Phase I Clinical Trial - Prepares for Phase II
11. Poniard Pharmaceuticals to Present New Data from Phase 2 Clinical Trials of Picoplatin in Multiple Tumor Types at the 45th Annual Meeting of the American Society of Clinical Oncology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2017)... 27, 2017 Medtec Europe ... more than 600 exhibitors from 70 countries the ... solutions that will advance the medical technology industry. ... the Messe Stuttgart, Stuttgart, Germany ... platform showcasing the key trends and insights across ...
(Date:3/27/2017)... , March 27, 2017  Sanderling Ventures, portfolio ... Ethicon, a division of Johnson & Johnson. Torax manufactures ... the treatment of gastro-esophageal reflux disease (GERD). The ... (MSA) technology and the procedure is currently available ... Torax Medical was founded by Sanderling Ventures, ...
(Date:3/27/2017)... March 27, 2017  Sophiris Bio Inc. (NASDAQ: ... a clinical late-stage biopharmaceutical company developing topsalysin (PRX302) ... today reported fourth quarter and full year 2016 ... Key Corporate Highlights: Advanced ... Cancer. During 2016, the Company reported successful results ...
Breaking Medicine Technology:
(Date:3/28/2017)... ... March 28, 2017 , ... Public relations pros work hard to earn ... business channels. , While many results are clear, much of PR is hard to ... When it comes to measurement, firms should always take an all-inclusive approach that takes ...
(Date:3/28/2017)... San Francisco, CA (PRWEB) , ... March 28, 2017 , ... ... restoration treatment, is proud to announce a new blog post about women’s hair loss. ... women suffer from hair loss as they age. Menopause or genetics can be two ...
(Date:3/28/2017)... ... March 28, 2017 , ... Nurse practitioners ... as their value increases in the healthcare workforce, according to a survey recently ... boards, career fairs, and candidate leads to healthcare employers of physicians and advanced ...
(Date:3/27/2017)... (PRWEB) , ... March 27, 2017 , ... New patients ... Braasch for leading sleep apnea treatment, with or without a referral. Sleep apnea is ... which can include daytime sleepiness, morning headaches and chronic snoring. , Dr. Braasch ...
(Date:3/27/2017)... ... , ... New patients who want to experience the benefits of dental ... placed by Dr. Manju Kejriwal, with or without a referral. Dr. Kejriwal is a ... of each dental implant placement. The i-CAT CBCT system captures the shapes of oral ...
Breaking Medicine News(10 mins):