A known molecule, delivered differently
Oxprofen™ is a novel, proprietary complex salt of ibuprofen, designed to absorb fast at the prescription dose.
How it works
Standard ibuprofen barely dissolves in the stomach, so absorption waits on its passage to the intestine, a step that varies widely from person to person. Oxprofen™ removes the wait. Through ion exchange, it releases ibuprofen already in solution, in the molecular, ionised form the body absorbs, while the Oxprofen matrix controls and caps the release so peak levels stay comparable to standard ibuprofen.
Fast, without the peak spike
Ibuprofen lysine and similar salts gain speed by raising peak plasma levels, which at prescription strength makes them unregistrable without new efficacy and safety trials. Oxprofen absorbs fast while keeping peak and overall exposure comparable to standard ibuprofen. That is what allows the bioequivalence route.
Human proof of concept
Exploratory human studies demonstrate substantially faster absorption while maintaining broadly comparable exposure.
Mean plasma ibuprofen levels from OAT-01 (Oxprofen against Brufen® 800 mg, exploratory proof-of-concept study), with the published ibuprofen analgesia-onset threshold overlaid (Mehlisch & Sykes 2013, 8.4 µg/mL, 95% CI 6.8 to 10.1).
About 40 minutes, against 2 hours 40
Median time to peak blood levels at the prescription dose. Peak exposure 100.4% and overall exposure 107.8% of standard ibuprofen.
More consistent, person to person
Individual times to peak ranged from 20 to 80 minutes on Oxprofen, against 1 to 4 hours on standard ibuprofen, in the same subjects.
Replicated at 200mg
The same faster profile was seen in two separate groups at 200 mg, and the fastest composition reached a median of 30 minutes, with peak levels matching standard ibuprofen.
Safety
116 subjects across three development studies, with no serious adverse events.
Exploratory study OAT-01 and earlier development studies, using early test formulations. Pilot PK will characterise the final tablet and powder drink.
Intellectual property
Oxprofen is protected by granted patents in the US, selected European countries, China and India, including a US composition-of-matter patent running to 2037, with further filings planned to extend protection.
Beyond ibuprofen
The technology is applicable to a range of anionic drugs and biomolecules, enabling control of how a drug is released and absorbed, and addressing stability, solubility, permeability and taste. Naproxen is the next candidate.
We welcome conversations with specialty pharmaceutical companies.