Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Tris Pharma Announces Two NDA Approvals

By Pharmaceutical Processing | December 7, 2009

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, has announced that the FDA has approved its first two New Drug Applications (NDAs) based on its proprietary OralXR+™ platform technology including the first-ever 24 hour liquid sustained release product. OralXR+ is a portfolio of dosage forms based on a patent-pending sustained release particles-driven technology. Tris creates extremely fine, taste-masked, sustained release particles that can deliver drug over time. The particles are coated with a highly flexile, insoluble, water based polymer resulting in highly durable particles that can be used in an array of dosage forms including liquid suspensions, ODT, chewable tablets, and film strips as well as traditional tablets or capsules. The NDA approvals received were for once-daily Clonidine ER Suspension and once-daily Clonidine ER Tablets in two different strengths. Clonidine, a heavily prescribed medication is a direct-acting alpha 2 adrenergic agonist which has been prescribed historically as an antihypertensive agent. Until Tris Pharma’s approval, there were no once-daily oral Clonidine products available. “The suspension represents a true leap forward for drug delivery in that it is the first-ever FDA approved 24 hour sustained release liquid formulation,” said Ketan Mehta, CEO and President of Tris Pharma. “These two NDAs further validate Tris’ pioneering work in the field of liquid sustained release. This is a testament to the people of Tris Pharma’s relentless work and dedicated efforts to make this a reality.” Liquid sustained release stands apart from traditional ER solid dose in that it allows physicians a limitless number of dose options since the dose can be customized through titration. It also allows patients who have difficulty swallow pills, typically young children and the elderly, realize the convenience and compliance benefits of drug delivery. “This will be particularly valuable as the technology is leveraged in the development of CNS, pain, and other important therapeutic dose-ranging compounds,” says Dr. Yu-Hsing Tu, Tris’ Head of R&D. Tris Pharma has a robust pipeline of more than 20 extended release products in different therapeutic categories currently in development.

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE