RNS9 May 2017 08:06
You asked they provided lol
Update regarding OXPzeroTM Ibuprofen Programmes
Oxford Pharmascience Group plc (AIM: OXP), the specialty pharmaceutical company that redevelops medicines to make them better, safer and easier to take, provides the following update on its OXPzeroTM Ibuprofen programmes, following its consideration of further FDA feedback.
Summary
· Feedback received from the US Food and Drug Agency (FDA) over-the-counter (OTC) division on OXPzeroTM Ibuprofen
· Consistent responses from both OTC and prescription (Rx) divisions requiring outcomes based endpoints in order to obtain approval for an OXPzeroTM Ibuprofen product making a GI safety claim
· Both FDA divisions have now confirmed that bioequivalent products which do not make the gastro-intestinal (GI) safety claim can be registered without requiring further efficacy data
· Further positive data from second phase of the exploratory pharmacokinetic (PK) study OAT-01 giving reassurance that bioequivalent formulations can be achieved
· The Company is carefully reviewing its next steps in terms of regulatory, clinical and commercial development
· Further announcements will be made in due course; the Company remains well-funded to pursue the commercial opportunities available to it
The Company announced on 31 March 2017 that it had received feedback from the FDA in respect of the Rx application of its OXPzero™ Ibuprofen platform. At that time, shareholders were advised that, following receipt of further feedback from the FDA division reviewing the OTC application and the Company's subsequent considered review in respect of both the OTC and Rx responses from the FDA, that the Company would be in a position to confirm its clinical development and commercial plans for its OXPzero™ Ibuprofen assets.
The Company confirms that it has now received the FDA's response to its pre-IND submission in relation to the OTC application of OXPzeroTM Ibuprofen. The response with regard to the OTC application is similar to that received for the Rx application, namely that, in order for OXP to be able to market an approved OXPzeroTM product making a gastro-intestinal (GI) safety claim, an outcomes based Phase III study would be required. Such a study would be longer and require a very large sample size relative to those originally envisaged by the Company using endoscopic data.
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