A clinical trial showed Dyanavel XR tablets were bioequivalent to the extended-release oral suspension formulation of Dyanavel.
Tris Pharma has launched Dyanavel XR (amphetamine) extended-release tablets to treat patients 6 years and older with attention-deficit hyperactivity disorder (ADHD). The FDA had approved the extended release tablets in November 2021.
In a clinical study in healthy adults, Dyanavel XR tablets were deemed to be bioequivalent to the extended-release oral suspension formulation of Dyanavel. In adults, a separate phase 3 trial published last month in the Journal of Clinical Psychiatry of the tablet formulation demonstrated statistically significant improvement in symptoms over patients who took placebo.
In children 6 to 12 years, a phase 3 trial showed the oral suspension demonstrated ADHD symptom improvement within one hour, that lasted through 13 hours after once-daily dosing. A separate exploratory study of the oral suspension appeared to improve ADHD symptoms as soon as 30 minutes after dosing.
“The Dyanavel XR tablet represents an important treatment option for patients with ADHD,” Andrew J. Cutler, M.D., chief medical officer, Neuroscience Education Institute and clinical associate professor of psychiatry, SUNY Upstate Medical University, said in a press release. “Knowing that ADHD in adults presents differently than in children, and as different adults have different treatment goals, Dyanavel XR once-daily tablet was designed and developed with the intent to provide adults with ADHD a treatment option that kicks in quickly and lasts throughout their workday and beyond.”
Dyanavel XR is a federally controlled substance because it contains amphetamine. It uses Tris’s LiquiXR platform technology, which allows for products with both immediate-release and extended-release characteristics and permits once-daily dosing.