Swedish regulator says Oxford Pharmascience can submit hybrid application for OTC product with OXPzero
Specialty pharmaceutical company, Oxford Pharmascience, said Monday it has received scientific advice from the Swedish regulatory authority, MPA, concerning the development programme requirements needed to support a future marketing authorisation application in Sweden for an OTC product containing OXPzero.
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The application, according to Oxford, could be submitted as a hybrid application, thanks to the well-established safety and efficacy of the reference ibuprofen product.
Oxford said MPA, unlike the UK regulatory authority, MHRA, considers the OXPzero Ibuprofen product to be bioequivalent to the reference product, meaning that those products could be registered in Sweden with only Phase I pharmacokinetic data.
The company also announced that formulations of OXPzeroTM Ibuprofen could, in principle, be registered with relatively low cost and low risk pharmacokinetic data in Sweden and potentially also in other EU countries.
Marcelo Bravo, chief executive officer of Oxford Pharmascience, commented: "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."