FDA Approves Extended Release Clonidine

I have to admit this one snuck up on me. I use clonidine frequently. It is clearly not a first line therapy, but in cases of resistant stage 2 hypertension it can be very effective. Until now there were two formulations. There is the oral clonidine tablets and the transdermal Catapres patch. The oral clonidine is cheap and effective but short acting (commonly prescribed three times daily) and often limited by side effects (fatigue and dry mouth). The Catapres patch is useful (although more expensive) and I have found has somewhat better tolerated by patients. The patch is worn for a week at a time and it helpful as add on therapy.

Now, seemingly out of nowhere, I found out today the FDA has approved Tris Pharma’s clonidine extended-release tablets and suspension for the treatment of hypertension. The suspension is the first available 24-hour liquid sustained-release doseform, allowing physicians to customize dosing options through titration. The new doseform will also help patients who have difficulty swallowing pills, such as young children and the elderly.

"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.

I look forward to adding this new option soon.