Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Supernus Updates Qelbree Label for ADHD & Breastfeeding Data
Details : Qelbree (viloxazine HCl) is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.
Product Name : Qelbree
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 27, 2025
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved
Sponsor : Moksha8 Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
M8 Pharmaceuticals Signs Exclusive Licensing Agreement for Qelbree® in Latin America
Details : An agreement aims to seek regulatory approval for Qelbree, an extended-release formulation of viloxazine for ADHD in children and adults.
Product Name : Qelbree
Product Type : Small molecule
Upfront Cash : Undisclosed
May 07, 2024
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Sponsor : Moksha8 Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Supernus Announces FDA Approval of Qelbree for the Treatment of ADHD in Adults
Details : At daily flexible-dose 200 to 600mg, Phase III trial met primary endpoint showing reduction change from baseline of Adult ADHD Investigator Symptom Rating Scale total score at end of study was statistically significantly greater in adults treated with Qe...
Product Name : Qelbree
Product Type : Small molecule
Upfront Cash : Not Applicable
April 29, 2022
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD
Details : The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.
Product Name : Qelbree
Product Type : Small molecule
Upfront Cash : Not Applicable
April 02, 2021
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Supernus Receives FDA Notice Assigning Early April 2021 PDUFA Date for SPN-812 NDA
Details : If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.
Product Name : SPN-812
Product Type : Small molecule
Upfront Cash : Not Applicable
February 22, 2021
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD
Details : At a daily dose of SPN-812 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 from baseline to end of study as measured by ADHD Investigator Symptom Rating...
Product Name : SPN-812
Product Type : Small molecule
Upfront Cash : Not Applicable
December 22, 2020
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : SPN-812, if approved by the FDA, will be the first truly new therapy to treat ADHD in a decade
Product Name : Undisclosed
Product Type : Small molecule
Upfront Cash : Not Applicable
January 22, 2020
Lead Product(s) : Viloxazine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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