Oxford Pharmascience has gotten pre-IND scientific advice from the US regulatory drugs and foods authority about 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.
According to the stock filling the company issued on Wednesday, the two key points from the advice are:
The OXPzero Ibuprofen drug substance is considered a new ibuprofen salt form and will need to be submitted through 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 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. As this is the understanding, the company noted that this will be further assessed once PK data are available with the final to-be-marketed OTC formulation.
Oxford said that further data will be required for US paediatric development.
The company said it is pleased that OTC formulations of OXPzero Ibuprofen can be registered in the US with relatively low cost and low risk pharmacokinetic data.
Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience, said: “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.”