M8 Pharmaceuticals, an Acino company, signs an exclusive licensing agreement with Supernus for Qelbree® (Viloxazine XR) in Latin America
Qelbree® (viloxazine extended-release capsule) which is approved in
Qelbree® (viloxazine extended-release capsules) is commercially available in
This strategic partnership is aligned with
"Supernus ran an extensive process to find the right partner Qelbree® to seek regulatory approval and successful commercialization in
"We are delighted to announce this collaboration with Supernus, a company with a fantastic track record of innovation in the CNS space and a robust pipeline of novel medicines to treat psychiatric and neurological disorders" said
About ADHD:
Attention deficit hyperactivity disorder (ADHD) is a common neurobehavioral disorder that affects millions of children and adults. Characterized by ongoing patterns of inattention, hyperactivity, and impulsivity, ADHD can significantly interfere with an individual's functioning and development.(1) Typically first diagnosed in childhood, up to 90% of patients have symptoms persisting into adulthood. The worldwide population prevalence is 7.2% in children and 2.5% in adults.1 When untreated, individuals with ADHD are prone to a wide range of poor outcomes such as, emotional problems, self-harm, substance misuse, educational under-achievement, difficulties with employment and relationships, and criminality (2). Adults with ADHD often have 4x higher risk of premature death, which can be even higher if they have additional psychiatric comorbidities such as substance use disorder.
- Wolraich ML, Hagan JF, Allan C, et al. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics 2019; 144: 20192528.
- https://www.thelancet.com/action/showPdf?pii=S2589-5370%2822%2900509-0
- https://applications.emro.who.int/docs/EMRPUB_leaflet_2019_mnh_214_en.pdf
About Viloxazine Extended-Release:
Viloxazine extended-release tablets is an innovative non-stimulant formulation, to be taken once daily.
In 6-8 week clinical trials, efficacy and improvement in symptoms were observed as early as 1 to 2 weeks. It has a proven safety and tolerability profile, with no evidence of abuse potential in clinical studies.
- In a study of children 6 to 11 years of age, ADHD symptom score reductions were statistically significant for doses of 100 mg and 200 mg, starting at week 1. (2)
- In the study of adolescents 12 to 17 years of age, reductions in ADHD symptom score were statistically significant for 400mg starting at week 2. (2)
- In the flexible dose study of adults 18 to 65 years of age, reductions in ADHD symptom score were statistically significant in Qelbree patients , starting in week 2. (2)
In
The Phase III study met the primary endpoint, showing that the reduction in change from baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score at the end of the study was statistically higher in adults treated with Qelbree® versus placebo (p=0.0040). Significant improvement in the AISRS subscale scores for inattention and hyperactivity/impulsivity symptoms were also observed in the study1. Additionally, the study met the key secondary efficacy endpoint with statistical significance (p=0.0023) in change from baseline in the Clinical Global Impression Scale – Illness Severity (CGI-S) at week 6. The active dose was well tolerated. (3)
About
M8 is a specialty biopharmaceutical company focused on licensing, marketing, and distributing innovative and established therapeutics in
About Acino
About
Supernus is a US-based pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. Our extensive expertise in product development and commercialization has been built over the past 30 years.
Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD and Parkinson's disease (PD). We are developing a broad range of new CNS product candidates that include depression, seizure disorders, narcolepsy and other CNS disease states,
For more information, visit www.supernus.com.
For media inquiries:
larisa.bernstein@acino.swiss
References:
- Qelbree-Prescribing-Info.pdf (supernus.com)
- https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-qelbreer-treatment-adhd-adults
- Nasser A, Hull JT,
Chaturvedi SA , Liranso T, Odebo O, Kosheleff AR, Fry N, Cutler AJ, Rubin J, Schwabe S, Childress A. A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Deficit/Hyperactivity Disorder. CNS Drugs. 2022 Aug;36(8):897-915. doi: 10.1007/s40263-022-00938-w. Epub 2022 Jul 27. PMID: 35896943; PMCID: PMC9328182.
View original content to download multimedia:https://www.prnewswire.com/news-releases/m8-pharmaceuticals-an-acino-company-signs-an-exclusive-licensing-agreement-with-supernus-for-qelbree-viloxazine-xr-in-latin-america-302136859.html
SOURCE