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Noven to Present Pivotal Study Results for Investigational Dextroamphetamine Transdermal System for Pediatric ADHD Patients


Press release content from Business Wire. The AP news staff was not involved in its creation.
Noven to Present Pivotal Study Results for Investigational Dextroamphetamine Transdermal System for Pediatric ADHD Patients
April 27, 2021 GMT
MIAMI & JERSEY CITY, N.J. (BUSINESS WIRE) Apr 27, 2021
Noven Pharmaceuticals, Inc., (“Noven”) a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced it will present the results of a multicenter, phase 2, laboratory classroom study which evaluated the safety and efficacy of its investigational dextroamphetamine transdermal system (“ATS”) in over 100 pediatric patients (ages 6-17 years) with ADHD at the 2021 virtual American Psychiatric Association (APA) Annual Meeting May 1-3, 2021. ....

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Supernus Pharmaceuticals : Current Report (SEC Filing - 8-K)


Qelbree (viloxazine extended-release capsules) represents the first novel non-stimulant treatment for ADHD in a decade
Supernus plans to make Qelbree available in the U.S. in 2Q 2021
ROCKVILLE, MD., April 2, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.
Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD, said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals. Qelbree provides prescribing physicians and patients living with ADHD a therap ....

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Supernus Higher as Pediatric ADHD Drug Is Cleared by FDA


Supernus Higher as Pediatric ADHD Drug Is Cleared by FDA
Supernus shares are higher after the Food and Drug Administration cleared the company to market a new ADHD drug for children.
Author:
Supernus Pharmaceuticals  (
The Rockville, Md., biopharmaceutical company s drug is called Qelbree, generically viloxazine.
The extended-release capsules treat attention-deficit hyperactivity disorder in kids 6 to 17 years old, Supernus said in a statement on Friday.
Supernus shares at last check were trading 11% higher at $29,55. 
The drug was cleared for marketing following “four Phase 3 clinical trials that studied more than 1,000 pediatric patients in that age range, Supernus said.
Qelbree is not a controlled substance, and it has proven efficacy and a tolerable safety profile,  Jack A. Khattar, Supernus s president and chief executive, said. ....

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