Supernus Pharmaceuticals ((SUPN)) announced an update on their ongoing clinical study.
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Study Overview: Supernus Pharmaceuticals is conducting a Phase 4 clinical study titled ‘A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit/Hyperactivity Disorder (ADHD)’. The study aims to evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in treating ADHD in young children, a significant step in addressing this condition in early childhood.
Intervention/Treatment: The study tests SPN-812, a viloxazine extended-release capsule, administered at 100mg once daily. It is compared against a placebo to determine its effectiveness in managing ADHD symptoms in preschool-aged children.
Study Design: This is an interventional study with a randomized, parallel assignment. It employs a quadruple masking approach, meaning the participant, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation. The primary purpose is treatment-focused.
Study Timeline: The study began on February 26, 2021, with the latest update submitted on October 7, 2025. These dates are crucial as they mark the progress and ongoing nature of the study, indicating active recruitment and data collection phases.
Market Implications: The successful development of SPN-812 could enhance Supernus Pharmaceuticals’ market position, potentially boosting its stock performance. Positive results might increase investor confidence, especially given the limited treatment options for ADHD in young children. Competitors in the ADHD treatment market will likely monitor these developments closely.
The study is currently recruiting, with further details available on the ClinicalTrials portal.