Oxford Pharmascience Group plc (AIM: OXP), the speciality pharmaceutical company that redevelops medicines to make them better, safer and easier to take, confirms that yesterday it received feedback from the FDA in respect of its pre-investigational new drug ('IND') meeting package for its OXPzero™ Ibuprofen prescription ('Rx') programme.
Whilst it will take some time to fully review the feedback received, the Company is disappointed to note that, although provisionally agreed by the MHRA in 2016, the FDA has not agreed with the proposed phase III study design based on endoscopic primary endpoints (frequency of erosions and ulcers). The FDA has indicated that in order to support an improved gastro-intestinal ('GI') safety claim, a clinical outcomes study would be required, including measures such as assessment of the incidence of peptic ulcer bleeding and related complications. Alternatively, the FDA has suggested the Company could pursue a claim of reduced GI symptoms only, without requiring such a clinical outcomes study. This suggestion will need to be considered carefully by the Company and its advisers before a decision is made on the development programme.
FDA feedback in respect of the Company's pre-IND meeting package for the OXPzero™ Ibuprofen over-the-counter ('OTC') programme remains outstanding but is expected shortly.
Following receipt and comprehensive review of both sets of feedback (in respect of OTC and Rx programmes), the Company will confirm its clinical development and commercial plans for OXPzero™ Ibuprofen.
Further announcements will be made as appropriate.
For further information:
|Oxford Pharmascience Group Plc|
|Marcelo Bravo, Chief Executive Officer||+44 207 554 5875|
|Aubrey Powell/Lauren Kettle||+44 20 7496 3000|
About Oxford Pharmascience Group Plc
Oxford Pharmascience Group Plc uses a range of proprietary technology platforms to re-develop existing medicines to make them better, safer or easier to take. The Company does not manufacture or sell its own pharmaceutical products direct to consumers but instead seeks to license its technologies and dossiers to a network of partners, mainly leading pharmaceutical companies with Rx (prescription) and OTC (Over the Counter) branded portfolios.
Oxford Pharmascience Group Plc focuses on existing medicines that are proven to be safe and effective but nevertheless still have associated issues and side effects often affecting compliance. By working with such medicines the Company is able to develop new innovative products for a fraction of the cost, in much quicker timescales and without the high risk of failure associated with developing new drugs.