The U.S. Food and Drug Administration (FDA) has approved the approval of Onida XR (Clonidine Attention-deficit hyperactivity disorder (Attention-deficit hyperactivity disorderDrug manufacturer Tris Pharma announced this in a statement.
This medication is the first approved liquid, non-stimulant ADHD treatment. The extended-release oral suspension, taken once daily at night, can be used alone or as an FDA-approved adjunctive therapy. Stimulation For pediatric patients aged 6 years and older.
“People with ADHD need a variety of treatment options designed to meet their individual needs because not every medication or treatment works for everyone,” Ann Childress, M.D., a psychiatrist and director of the Las Vegas-based Center for Psychiatry and Behavioral Medicine, said in a statement.
“The approval of Onida XR, the only liquid, non-stimulant ADHD treatment with an altered release profile for nighttime dosing, provides a convenient option for patients needing better ADHD control,” she added.
The approval was based on “adequate and well-controlled studies” of the company’s extended-release tablets.
Onyda XR is contraindicated in patients with a history of hypersensitivity reactions to clonidine.
The drug may cause a dose-dependent decrease in blood pressure and heart rate. Vital signs should be monitored frequently in at-risk patients. In studies of the extended-release tablet, somnolence and sedation were commonly reported side effects.
The sympatholytic effects of clonidine may be exacerbated Sinus node dysfunction and Atrioventricular blockThe company noted that this tendency was particularly pronounced in patients taking other sympathetic nervous system suppressants.
Onyda XR is expected to be available in pharmacies in the second half of 2024.
Alicia Ault is a freelance journalist based in St. Petersburg, Florida, whose work has appeared in publications such as: JAMA and Smithsonian.com. You can find her at X @aliciaault.
