Oxprofen™ Rx
One active ingredient, a franchise of prescription products, developed first for the US market through the FDA 505(b)(2) pathway.
Two products, both heading to pilot PK
Oxprofen tablet
400 mg tablet; prescription dose 800 mg (2 × 400 mg). Reaches peak blood levels as quickly as diclofenac potassium, with the safety and efficacy of ibuprofen. Target time to peak: about 40 to 45 minutes.
Oxprofen powder drink
A single-dose 600 mg sachet, taken as a hot or cold drink, for maximum speed. Target time to peak: about 30 minutes.
Target times are based on results in exploratory clinical studies; the final formulations have yet to be tested. Diclofenac potassium comparison based on the FDA label for Cataflam® (mean time to peak 1.0 hour); not a head-to-head study.
Already shown in people: about 40 minutes, against 2 hours 40
Median time to peak blood levels at the prescription dose, Oxprofen against standard ibuprofen, with comparable overall exposure and a much tighter range from person to person. Exploratory human study OAT-01.
Approval based primarily on bioequivalence
Known active ingredient: ibuprofen, in use for over 60 years.
Known safety profile: no new safety programme required.
Bioequivalence-led pathway: leverages established ibuprofen efficacy.
Limited clinical programme: pilot PK, then pivotal bioequivalence.
FDA pre-IND interactions and MHRA Scientific Advice are complete, supporting a bioequivalence-led development strategy.
The franchise
Next
An Oxprofen and triptan combination tablet for migraine, a migraine label for the powder drink, and an Oxprofen and paracetamol combination tablet.
Then
Markets outside the US, and OTC.
We welcome conversations with specialty pharmaceutical companies.