Supernus Pharmaceuticals (SUPN) - Get Supernus Pharmaceuticals, Inc. Report shares jumped on Wednesday after the drugmaker focused on the central nervous system reported progress in a Phase 3 study of an attention-deficit-hyperactivity-disorder drug.
Supernus recently traded at $26.70, up 19%. The stock remains off 2% year to date.
“At a daily dose of up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD,” the company said in a statement.
“In addition to meeting the primary efficacy endpoint, the study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in the change from baseline of the Clinical Global Impression – Severity of Illness Scale at week six. The active dose was well tolerated.”
Further, “SPN-812 is under review by the U.S. Food and Drug Administration for the treatment of ADHD in pediatric patients 6 to 17 years of age,” Supernus said.
“As announced in November, the FDA issued a Complete Response Letter … to indicate that the review cycle for the application was complete and that the application is not ready for approval in its present form. The company will be meeting with the FDA in January 2021 to discuss the [letter.]”
As for Supernus’s reaction to the test results, “These compelling data in adults will be important for our planned [supplemental new-drug application] 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.,” Chief Executive Jack Khattar said in a statement.
“We now have positive Phase 3 data proving the efficacy and safety of SPN-812 in a broad range of ADHD patient populations; children 6-11 years old, adolescents 12-17 years old, and adults.”