Oxprofen™ – Next-Generation Ibuprofen
Oxprofen™ is the ibuprofen implementation of the OXPzero™ platform, engineered to deliver rapid onset while maintaining controlled systemic exposure.
Clinical Evidence
• Bioequivalent to standard ibuprofen for AUC and Cmax
• Median Tmax ≈30 minutes in a direct head-to-head human PK study versus fast-acting ibuprofen lysine (Tmax ≈40–45 minutes)
• Demonstrates that rapid onset can be achieved without increasing Cmax beyond standard ibuprofen exposure levels
• Intrinsic taste masking enabling consumer-relevant formats
• Early endoscopy data suggest reduced irritation potential relative to standard formulations
Market Applications
• OTC: Fast-acting, taste-masked ibuprofen enabling differentiated consumer formats
• Rx: Acute pain development programme in the United States, designed to support a 505(b)(2) pathway and potential long-term lifecycle opportunities including prescription-to-OTC switch
Regulatory Pathway
Designed for registration via the 505(b)(2) pathway in the United States and 10(3) hybrid pathway in the European Union, with flexibility for direct OTC registration depending on jurisdiction.
Development Status
Phase 1 human pharmacokinetic studies completed. Regulatory consultations with FDA and EMA confirm suitability for established 505(b)(2) and hybrid regulatory pathways.
Prescription Development Pathway
Oxprofen is positioned for progression in the United States via a 505(b)(2) regulatory pathway for the treatment of acute pain. The programme builds on completed human pharmacokinetic data and leverages the established safety profile of ibuprofen within a regulatorily familiar framework.
The prescription pathway is designed to establish a clinically differentiated rapid onset NSAID profile, creating the foundation for potential lifecycle expansion into consumer health.
Pipeline Extensions
The OXPzero™ platform is being extended to naproxen. Human PK studies have demonstrated bioequivalence to naproxen acid, while in vitro data show that release kinetics can be engineered analogously to Oxprofen™. This supports development of a differentiated family of NSAIDs under a single IP-protected formulation architecture.
Intellectual Property – Granted and pending patents across major markets covering LDH-NSAID compositions, ion-exchange processes, and platform implementations.
Contact: contact@pharmascience.co.uk