Oxford Pharmascience has received scientific advice from the MPA (Swedish regulatory authority) about the development programme for future marketing authorisation application (MAA) in Sweden for an OTC product containing OXPzero Ibuprofen.
The company said on Monday that the application can be submitted as a hybrid application , which means that additional safety and efficacy studies are not considered necessary.
Oxfor Pharmascience said that unlike the Uk regulatory authority MHRA, the MPA considers the OXPzero Ibuprofen product to be bioequivalent to the reference product. In turn, this mens that OXPzeroTM products will be capable of registration in Sweden with only Phase I pharmacokinetic data.
The company also said is welcomed this as the OTC formulations of OXPzeroTM Ibuprofen can in principle be registered with relatively low cost and low risk pharmacokinetic data in Sweden and potentially in other EU countries. Advice on the US development requirements is expected from FDA in the coming weeks.
Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, said that the advice has been very informative to map out portfolio product development strategies. He said it was 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,” Bravo said.