Oxford Pharmascience : FDA Pre-IND Advice on OXPzero™ Ibuprofen OTC Opportunity

29 November 2017

FDA Pre-IND Advice on OXPzero™ Ibuprofen OTC Opportunity

Oxford Pharmascience, the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, today announces it has received pre-IND scientific advice from the FDA (US regulatory authority) regarding the development programme requirements likely to be needed to support a future new drug application ('NDA') in the US for an OTC product containing OXPzero™ Ibuprofen. Key points from the advice are:

• The OXPzero™ Ibuprofen drug substance is considered a new ibuprofen salt form and hence will need to be submitted as a 505(b)(2) application (which is typically a faster route to approval than a traditional development path), as it bridges to the well-established safety and efficacy of the reference ibuprofen product.
• Based on the FDA responses, the understanding is that the US NDA can be submitted with only Phase I PK data and that no further safety or efficacy studies are required to licence the product for use in adults, however this will be further assessed once PK data are available with the final to-be-marketed OTC formulation.
• Further data will be required for US paediatric development.

The Company is pleased that OTC formulations of OXPzero™ Ibuprofen can, in principle, be registered in the US with relatively low cost and low risk pharmacokinetic data.

Subject to completion of the planned demerger (as announced on 10 November 2017 and described in detail in the Circular sent to shareholders on the same date), the OXPzero™ platform will be owned by the separate private entity, Oxford Pharmascience Limited ('OPL') (currently a subsidiary of the Company). OPL will continue with the ongoing commercialisation of the OXPzero™ platform assets in both OTC and prescription markets.

Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, commented:

'This FDA advice underpins our product development strategy for the US OTC market and it is encouraging that our novel, taste-masked OXPzero™ Ibuprofen formulations can be developed for approval in the US without the need for costly Phase III trials.'

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