Oxford Pharmascience’s OXPzero Ibuprofen can act faster in a human study compared to its bioequivalent

Oxford Pharmascience’s interim PK study showed that the technolology modifications can not only make OXPzero Ibuprofen bioequivalent to OTC Nurofen, but also potentially faster acting, the drugmaker said in an update on OXPzero Ibuprofen clinical program, for which on January 17, it kicked off dosing healthy patients in the first phase of the study. 

The company, which focuses on redeveloping medicines, is undertaking this three-part OAT 01 study to see if its lead product compared to licensed ibuprofen products shows lab-seen improvements, on healthy humans.

According to Oxford Pharmascience, the interim PK data from the first part of the study in 10 subjects showed that the technology modifications can successfully change the PK profile of ibuprofen released into the body from OXPzero Ibuprofen and that it is possible to achieve a PK profile comparable to Nurofen displaying equivalent maximum plasma levels (Cmax), equivalent total absorption of ibuprofen (AUC), and a faster rate of absorption (Tmax).

In addition, alternative technology modifications can also achieve a PK profile for OXPzero Ibuprofen with a slower rate of release and extended duration of effect as compared to Nurofen, the company said.

The company said it will go on with the OAT 01 as planned and it said it won’t announce further results because the details are under UK patent application. The international filings are to be expanded over the next two years, Oxford Pharmascience said.

Commenting on the results, CEO Marcelo Bravo said: “Achieving a product that is bioequivalent to reference is highly important to OXP as the regulatory pathway to gaining product approval generally becomes faster, simpler and therefore less costly for bioequivalent products.  The potential to accelerate speed of action or to extend the duration of effect is expected to further differentiate prospective OXPzero products. 

“These results indicate a strong position with an OXPzero Ibuprofen asset that can be made bioequivalent, completely taste masked and either faster acting or having an extended duration of effect compared to the reference product.”