Oxford Pharmascience says FDA disagrees with OXPzero proposed phase III study
Shares in Oxford Pharmascience plunged by more than a third after the US Federal Drug Administration (FDA) did not agree with the proposed phase III study design for prescription OXPzero Ibuprofen programme based on endoscopic primary endpoints.
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"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," said Oxford Pharmascience.
Alternatively, the FDA has suggested Oxford Pharmascience 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," it said, noting the drug was provisionally agreed by the UK's Medicines and Healthcare products Regulatory Agency in 2016.
Oxford Pharmascience said it was disappointed by the FDA's non-agreement, and that it would take some time to fully review the feedback received.
"Following receipt and comprehensive review of both sets of feedback ... the company will confirm its clinical development and commercial plans for OXPzero Ibuprofen."
At 12:56 GMT, shares in AIM-quoted Oxford Pharmascience were down 33.88% to 2p each.