FDA Approves Expanded Use Of Supernus' Viloxazine In Adult ADHD Patients

The FDA approved an expanded indication for Supernus Pharmaceuticals Inc's SUPN Qelbree (viloxazine extended-release capsules) for attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older.
The FDA has now approved Qelbree for ADHD in children (starting at age 6), adolescents, and adults.
Qelbree is a novel non-stimulant taken once daily for full-day exposure.
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The approval is based on positive results from the Phase 3 study.
At a daily flexible-dose between 200mg to 600mg, the Phase 3 trial met the primary endpoint showing the reduction in the change from baseline of the Adult ADHD score was statistically significantly more significant in adults treated with Qelbree versus placebo.
Price Action: SUPN shares are up 3.58% at $28.90 during the market session on the last check Monday.