Supernus Pharmaceuticals Inc SUPN announced Monday that its SPN-812 — a commercial treatment for patients with Attention Deficit Hyperactivity Disorder (ADHD), exhibited positive topline results in late-stage trials.
What Happened Supernus claimed that the daily active 600mg dose of the SPN-812 cleared the primary and secondary efficacy endpoints. The U.S. Food and Drug Administration (FDA) is further reviewing the treatment’s efficacy for pediatric patients between the ages of six to 17 years.
Supernus disclosed that if the treatment is approved for pediatric ADHD patients, the pharma company intends to seek FDA approval sometime in the second half of next year for its use in adult patients.
Why Does It Matter: The company believes that SPN-812’s unique pharmacological and pharmacokinetic profile makes it a crucial non-stimulant treatment alternative.
Talking about the Phase 3 trial results, Supernus President and CEO Jack Khattar, said that “these compelling data in adults will be important for our planned sNDA submission to make this treatment option available, if approved by the FDA, to the adult ADHD patient population, which represents approximately half of the total ADHD market in the U.S.”
Price Action: SUPN stock rallied 24.29% higher in Tuesday’s post-trading hours to close at $27.99, after hitting an intra-session high of $34.89.
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