The MPA, Swedish regulatory authority, has offered scientific advice to United Kingdom-based Oxford Pharmascience for the development program requirements likely to be necessary to support a future marketing authorisation application in Sweden for an OTC product containing OXPzero Ibuprofen, it was reported yesterday.

The main points from the advice are; firstly, that the application can be submitted as a hybrid application (under article 10(3) of Directive 2001/83/EC), connecting the well-established safety and efficacy of the reference ibuprofen product (meaning that additional safety and efficacy studies are not considered necessary). Secondly, the MPA considers the OXPzero Ibuprofen product to be bioequivalent to the reference product. This guidance indicates that OXPzeroTM product will be capable of registration in Sweden with only Phase I pharmacokinetic data.

Advice on the US development requirements is expected from FDA in the coming weeks.

Marcelo Bravo, chief executive officer of Oxford Pharmascience, said, 'The MPA advice has been very informative to us as we map out our portfolio product development strategies and it's pleasing to know that novel, taste-masked OXPzeroTM Ibuprofen formulations can be developed for approval in Sweden without the need for costly Phase III trials. This gives us encouragement that, subject to further scientific advice discussions with relevant country regulators and the acceptance of marketing authorisation applications by the same bodies when filed, a similar approach may be acceptable in other EU countries.'