The FDA had accepted for review Tris Pharma's New Drug Application for its extended-release liquid amphetamine to treat ADHD in children.
The FDA had accepted for review Tris Pharma’s New Drug Application for its extended-release (ER) liquid amphetamine (Dyanavel XR) to treat ADHD in children.
"Even though amphetamines are profoundly effective in treating ADHD, current formulations are less than ideal for pediatric patients who have difficulty swallowing pills," stated Ann Childress, MD, an investigator in Dyanavel XR’s phase 3 efficacy study on which the application was based. "As an ER liquid amphetamine formulation with a great duration of action, Dyanavel XR has the potential to fulfill an important unmet patient need."
Tris developed Dyanavel XR through its LiquiXR technology that provides sustained-release delivery of drugs in oral liquid form, so patients do not have to swallow a pill.
Dr. Childress noted currently available capsule amphetamine formulations can be sprinkled or dissolved, but “patients may not ingest all of the product—or worse, may chew the sprinkles causing dose dumping.”
The FDA is expected to act on Dyanavel XR’s approval submission in mid-October 2015.
“We are proud to have completed our clinical program studying the safety and efficacy of Dyanavel XR in children with ADHD,” stated Tris chief medical officer Sally Berry, MD, PhD. “We look forward to working with the FDA throughout the review process.”