FDA Approves New Sustained Release Drug Applications

7 December 2009 (Last Updated December 7th, 2009 18:30)

Tris Pharma has received clearance from the US Food and Drug Administration (FDA) for two New Drug Applications (NDAs) based on its proprietary OralXR+ platform technology, including a first-ever 24-hour liquid sustained-release product. The OralXR+ platform is based on patent-pending sus

Tris Pharma has received clearance from the US Food and Drug Administration (FDA) for two New Drug Applications (NDAs) based on its proprietary OralXR+ platform technology, including a first-ever 24-hour liquid sustained-release product.

The OralXR+ platform is based on patent-pending sustained-release particle-driven technology, which uses particles coated with highly flexile, insoluble, water-based polymer that can be used in an array of dosage forms delivered over time.

The NDA approvals are for once-daily Clonidine ER Suspension and once-daily Clonidine ER Tablets in two different strengths. Clonidine is a direct-acting alpha 2 adrenergic agonist that has historically been prescribed as an antihypertensive agent.

Tris Pharma CEO and president Ketan Mehta said that the suspension represents a true leap forward for drug delivery as the first-ever FDA-approved 24-hour sustained-release liquid formulation.

Liquid sustained release carries an advantage over traditional ER solid dose in that it allows doses to be customised and can also provide benefits for people who have difficulty swallowing pills.