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1 products found

pp-050

Oral suspension

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
For pediatric attention-deficit/hyperactivity disorder (ADHD); also designed with a profile expected to benefit patients with autism spectrum disorder (ASD) who often have overlapping ADHD symptoms and difficulty with solid oral dosage forms. Phase 2 clinical development. Extended-release oral suspension formulation of a known ADHD therapeutic class. Designed to provide sustained symptom control throughout the day via extended-release delivery, improving adherence and reducing symptom rebound common with immediate-release ADHD medications. Route / form: Once-daily oral suspension (extended-release). Differentiation: Child-friendly liquid formulation for patients who cannot swallow tablets; smoother all-day coverage; expected applicability for children with ASD who may have dosing, sensory, or adherence challenges.
Manufacturer #18873

A privately-held, mid-size biopharma firm focused on developing and marketing therapies for ADHD, pain, addiction and CNS disorders. It combines proprietary drug-delivery technology with global development and licensing efforts to deliver patient-friendly medications worldwide.

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