pp-049 Tablets, extended release (ER)
Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
For spasticity associated with multiple sclerosis (MS) and other neurological conditions such as cerebral palsy.
Phase 1 clinical development.
Optimized, extended-release pharmaceutical formulation of an existing standard spasticity therapy.
Designed to improve delivery and tolerability of the current standard of care for spasticity; aims to provide smoother therapeutic effect and reduce peaks associated with adverse effects.
Route / form: optimized, extended-release pharmaceutical formulation.
Differentiation: Intended to provide more consistent daily symptom control, better adherence, and fewer side effects compared with existing formulations of standard spasticity treatments.
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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