Shots:

• The approval was based on the P-III study to evaluate Dyanavel XR tablets vs PBO in patients aged 6 to 12yrs. with ADHD
• The results showed that patients treated with Dyanavel XR ER tablets were bioequivalence to Dyanavel XR ER oral suspension, improvement in ADHD symptom within 1hrs., improvement in mean PERMP-T scores across all post-dose time points measured. Patients with Dyanavel XR oral suspension can switch to the same dose of Dyanavel XR tablets
• In an exploratory study, Dyanavel XR oral suspension showed an improvement of ADHD symptoms in 30 min. after dosing. Dyanavel XR is a federally controlled substance (CII) & are expected to be available in Q1’22

Ref: Tris Pharma| Image: Tris Pharma