M8 Pharmaceuticals signs licensing agreement with Supernus

M8 Pharmaceuticals has signed an exclusive licensing agreement with Supernus Pharmaceuticals to seek regulatory approval and commercialize Qelbree under M8’s trademark in Latin America. Qelbree 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 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 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, Qelbree was approved by the US Food and Drug Administration 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. 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.