M8 Pharmaceuticals, an Acino company ('M8') announces that the company has signed an exclusive licensing agreement with Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) ('Supernus'), a biopharmaceutical company focused on the development and commercialization of products for the treatment of diseases of the central nervous system (CNS), to seek regulatory approval and commercialize Qelbree (Viloxazine XR) under M8's trademark in Latin America.
Qelbree (viloxazine extended-release capsule) which is approved in the United States is an extended-release formulation of viloxazine, a selective norepinephrine reuptake inhibitor to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. Unlike most ADHD medications on the market, this medication is a non-stimulant option.
Qelbree (viloxazine extended-release capsules) is commercially available in the United States as a prescription medicine to treat ADHD in patients 6 years of age and older. Based on the results of four pivotal trials,1-4 Qelbree was approved by the US Food and Drug Administration (FDA) in 2021 for the treatment of children 6-17 years of age and in 2022 for the treatment of adults. Qelbree is also currently being studied in several phase 4 clinical trials, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive topline results reported in September 2023). A second phase 4 clinical trial in preschool age children with ADHD is planned to commence in January 2024. A third phase 4 clinical trial is studying the impact of Qelbree on co-morbid mood symptoms prevalent in patients with ADHD.
This strategic partnership is aligned with Acino's mission to provide Latin American patients access to innovative medicines and strengthen its leadership position in the central nervous system therapeutic space. The collaboration will provide prescribers with a new option to improve the ADHD treatment paradigm for millions of patients.
"Supernus ran an extensive process to find the right partner Qelbree to seek regulatory approval and successful commercialization in Mexico and Brazil" said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Supernus is proud to support other regions and patients in need of innovative solutions to overcome the challenges of treating a complex disease such as ADHD."
"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 Joel Barlan, Head of Latin America at Acino.