Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Oxford Pharmascience has received scientific advice from the MPA (Swedish regulatory authority) with respect to the development program requirements likely to be required to support a future marketing authorisation application (MAA) in Sweden for an OTC product containing OXPzero Ibuprofen.
Subscribe to our email newsletter
Key points from the advice are:
The application can be submitted as a hybrid application (under article 10(3) of Directive 2001/83/EC), bridging to the well-established safety and efficacy of the reference ibuprofen product (meaning that additional safety and efficacy studies are not considered necessary)
Unlike the MHRA (the UK regulatory authority), the MPA considers the OXPzero™ Ibuprofen product to be bioequivalent to the reference product. This guidance indicates that OXPzeroTM product(s) will be capable of registration in Sweden with only Phase I pharmacokinetic data.
The Company is pleased that 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 (subject to further scientific advice discussions and MAAs to be filed with regulators in the those countries). Advice on the US development requirements is expected from FDA in the coming weeks.
Should the proposed demerger (as announced on 10 November 2017 and described in detail in the Circular sent to shareholders on the same date) complete, the OXPzeroTM platform will be owned by the separate private entity, Oxford Pharmascience Limited (currently a subsidiary of the Company).
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."