FDA approves two New Drug Applications

Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced that the US Food and Drug Administration (FDA) has approved its first two New Drug Applications (NDAs) based on its proprietary OralXR+(TM) 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.