Oxford Pharmascience Group PLC FDA Feedback on OXPzeroT Ibuprofen Rx Programme (1026B)
March 31 2017 - 2:01AM
UK Regulatory
TIDMOXP
RNS Number : 1026B
Oxford Pharmascience Group PLC
31 March 2017
31 March 2017
Oxford Pharmascience Group plc
("Oxford Pharmascience" or the "Company")
FDA Pre-IND Feedback on OXPzero(TM) Ibuprofen Rx programme
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(TM) 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(TM) 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(TM) Ibuprofen.
Further announcements will be made as appropriate.
Contacts:
Oxford Pharmascience Group
plc
Marcelo Bravo, Chief Executive
Officer +44 20 7554 5875
N+1 Singer
Aubrey Powell +44 20 7496 3000
Lauren Kettle
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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