FDA Approves Extended-Release Clonidine

Yael Waknine

December 10, 2009

December 10, 2009 — The US Food and Drug Administration (FDA) has approved the first once-daily oral formulations of clonidine (Tris Pharma) for the treatment of hypertension.

Clonidine extended-release tablets and suspension are based on proprietary sustained-release particles-driven technology (OralXR+) that can be used in a variety of dosage forms, including orally dispersible tablets, chewable tablets, and film strips.

"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," noted Ketan Mehta, chief executive officer and president of Tris Pharma, in a company news release.

The new dose form will allow individualized dose titration and help patients who have difficulty swallowing pills, such as young children and the elderly.