SUPN - FDA OKs Supernus' Qelbree for treatment of ADHD

The FDA has approved Supernus Pharmaceuticals' (SUPN) Qelbree (SPN-812) (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder ((ADHD)) in pediatric patients 6 to 17 years of age. The approval of Qelbree is supported by data from a development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD and plans to submit a sNDA for Qelbree in H2 2021.

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FDA OKs Supernus' Qelbree for treatment of ADHD