Oxford Pharmascience upbeat on latest OXPzero advice
Updated : 15:26
Specialty pharmaceutical redeveloper Oxford Pharmascience has received pre-IND scientific advice from the US FDA, it announced on Wednesday, regarding the development programme requirements likely to be needed to support a future new drug application for an over-the-counter product containing OXPzero Ibuprofen.
The AIM-traded firm said key points from the advice included that the OXPzero Ibuprofen drug substance was considered a “new ibuprofen salt form”, and thus would need to be submitted as a 505(b)(2) application as it bridges to the well-established safety and efficacy of the reference ibuprofen product.
Oxford said the 505(b)(2) application was typically a faster route to approval than a traditional development path.
The company also said that, based on the FDA’s responses, its understanding is that the new drug application could be submitted with only Phase I pharmacokinetic data, and that no further safety or efficacy studies were required to licence the product for use in adults.
That, however, would be further assessed once PK data was available with the final to-be-marketed over-the-counter formulation.
Further data would also be required for US paediatric development, the Oxford board added..
“The company is pleased that over-the-counter formulations of OXPzero Ibuprofen can, in principle, be registered in the US with relatively low cost and low risk pharmacokinetic data,” the Oxford Pharmascience board said in its statement.
Subject to completion of the planned demerger, as announced on 10 November and described in detail in a circular sent to shareholders, the company said the OXPzero platform would be owned by the separate private entity Oxford Pharmascience Limited (OPL).
OPL would continue with the ongoing commercialisation of the OXPzero platform assets in both over-the-counter and prescription markets.
“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,” said chief executive Marcelo Bravo.