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Benzinga
Benzinga
Technology
Vandana Singh

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

FDA ADHD SUPN Deficit
  • The FDA approved an expanded indication for Supernus Pharmaceuticals Inc's (NASDAQ: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. 
  • Related: Supernus Bolsters Parkinson's Portfolio With $450M Adamas Buyout: Highlights.
  • 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.
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