US FDA clears “first-ever” 24hr liquid SR drug
The two newly approved products, a liquid and a tablet formulation of the alpha-2 adrenergic agonist Clonidine, both employ Tris' sustained-release (SR) OralXR+ particle technology to deliver their contents over a 24 hour period.
Tris’ OralXR+ platform uses particles coated in an insoluble, taste-masked, water-based polymer that is compatible with a variety of dosage forms, ranging from tablets and capsules to liquid suspensions and film strips.
Clonidine has traditionally been prescribed for hypertension, however it has a variety of other uses ranging from the treatment of narcotic withdrawal and migraine to attention-deficit hyperactivity disorder (ADHD).
And, while in general, the availability of once-daily oral Clonidine formulations will be welcomed by patients using the drug for an extended period, the Food and Drug Administration's (FDA) decision has wider implications.
This is because, for the first time, a delivery platform combining 24-hour SR technology with the ultra accurate adjustments available to liquid formulations has been granted marketing approval, which, as Tris' head of R&D, Yu-Hsing Tu, explained, offers significant dosing advantages.
“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.”
Dr Tu added that, in addition to being easier to swallow than pills, liquid formulations “will be particularly valuable… in the development of [central nervous system] CNS, pain and other important therapeutic dose-ranging compounds.”
Tris CEO Ketan Mehta echoed these thoughts, suggesting that, in particular, the Clonidine suspension “represents a true leap forward for drug delivery in that it is the first-ever FDA approved 24 hour sustained-release liquid formulation.”
