Supernus Pharmaceuticals (SUPN) – Get Report shares jumped on Wednesday following the drugmaker concentrated on the central nervous system documented progress in a Phase 3 examine of an attention-deficit-hyperactivity-disorder drug.
Supernus recently traded at $26.70, up 19%. The stock stays off 2% calendar year to date.
“At a day by day dose of up to 600mg, the trial satisfied the key endpoint with robust statistical significance (p=.0040) as opposed to placebo in improving upon the indications of ADHD,” the business reported in a statement.
“In addition to conference the major efficacy endpoint, the research achieved the key secondary efficacy endpoint with statistical significance (p=.0023) in the modify from baseline of the Clinical World wide Impression – Severity of Disease Scale at week six. The lively dose was perfectly tolerated.”
Even more, “SPN-812 is under assessment by the U.S. Food and Drug Administration for the treatment of ADHD in pediatric individuals 6 to 17 many years of age,” Supernus said.
“As announced in November, the Food and drug administration issued a Complete Reaction Letter … to show that the overview cycle for the application was comprehensive and that the software is not prepared for approval in its existing form. The organization will be assembly with the Food and drug administration in January 2021 to examine the [letter.]”
As for Supernus’s response to the check effects, “These persuasive knowledge in adults will be critical for our prepared [supplemental new-drug application] submission to make this remedy selection obtainable, if accepted by the Fda, to the grownup ADHD patient inhabitants, which signifies approximately fifty percent of the total ADHD sector in the U.S.,” Main Govt Jack Khattar mentioned in a assertion.
“We now have good Stage 3 facts proving the efficacy and basic safety of SPN-812 in a broad vary of ADHD individual populations little ones 6-11 years previous, adolescents 12-17 years outdated, and grown ups.”