Oxford Pharmascience Successful Pilot Clinical Study

Successful Pilot Clinical Study of OXPzero(TM) Naproxen
Oxford Pharmascience, the specialty pharmaceutical company /></span></a> that redevelops medicines to make them better, safer and easier to take, today announces that the pilot comparative pharmacokinetics (PK) study of OXPzero(TM) Naproxen (OXP 005), which commenced on 5 March, has been successful and the headline data from the trial demonstrates bioequivalence of OXP005 to Naprosyn(R) (generic naproxen).</p>
<p> OXPzero(TM) Naproxen aims to deliver 250mg of reduced gastric irritation naproxen via the Company’s patent protected OXPzero(TM) <a id=itxthook3 class=itxtnewhook itxthook style=font-weight: normal; font-size: 100%; font-style: normal; text-decoration: none; border: 0px none transparent; padding: 0px; background-color: transparent; background-image: none; display: inline; href=http://uk.advfn.com/cmn/fbb/thread.php3?id=25679562&from=554 rel=nofollow><span id=itxthook3p class=itxtrst itxtrstspan itxtnowrap><span id=itxthook3w class=itxtrst itxtrstspan itxtnowrap itxtnewhookspan style=font-weight: normal; font-size: 100%; text-decoration: underline ! important; border-width: 0px 0px 1px; border-style: none none solid; border-color: transparent transparent #00cc00; padding: 0px 0px 1px ! important; color: #009900; background-color: transparent;>technology</span><img id=itxthook3icon class=itxtrst itxtrstimg itxthookicon style=padding-top: 0px!important; padding-right: 0px!important; padding-bottom: 0px!important; padding-left: 4px!important; vertical-align: baseline!important; margin: 0px!important; src=http://images.intellitxt.com/ast/adTypes/icon1.png alt= in an immediate release oral formulation in order to provide a significantly reduced gastrointestinal (GI) side effect profile compared to standard naproxen tablets.

The headline PK data /></span></a> showed results which demonstrate bioequivalence and that the OXPzero(TM)technology has been successfully optimised to enable immediate and complete drug release.</p>
<p> Full results of the study will be published in the following weeks. Based on this data, the company will now progress to a proof of concept endoscopy study to demonstrate the reduced GI irritation benefit of OXPzero(TM) Naproxen, as was previously demonstrated for OXPzero(TM) Ibuprofen in an earlier formulation.</p>
<p> Non-steroidal anti-inflammatory drugs (NSAIDs) are one of the most widely used classes of drugs, with combined annual sales in excess of $12 billion and more than 30 million users worldwide consuming NSAIDs each day (source: Evaluate Pharma). Chronic use of NSAIDs causes well-documented GI side effects, including ulcers and bleeding, and leads to significant morbidity and mortality in a substantial number of patients, with significant associated healthcare costs. The OXPzero(TM) platform technology reduces these risks and is being selectively applied to the most commonly used NSAID molecules, namely ibuprofen, naproxen, diclofenac and aspirin.</p>
<p> Marcelo Bravo, Chief Executive Officer of Oxford Pharmascience commented:</p>
<p> Demonstrating the bioequivalence of immediate release OXPzero(TM) Naproxen is a great result and a significant milestone for Oxford Pharmascience. This allows us to proceed with confidence to the endoscopy trial to demonstrate the reduced gastric irritation benefit of OXPzero(TM) Naproxen, and also confirms that the technology has been successfully optimised to achieve immediate and complete drug release. Oxford Pharmascience will now continue to progress confidently with our clinical programmes for both OXPzero(TM) Naproxen and OXPzero(TM) Ibuprofen.</p>
<p> Further information about the study:</p>
<p> The randomised pilot PK study, which was conducted by Quotient Clinical in the UK, was a single-dose, two arm study between OXPzero(TM) Naproxen and the reference Naprosyn(R) 250mg tablets with ten subjects in each arm. Headline PK data show mean AUC (Area Under the Curve or total drug exposure over time) and mean C(max) (maximum serum concentration) results meet the bioequivalence criteria, demonstrating that the OXPzero(TM) technology has been successfully optimised to enable immediate and complete drug release. Further details about the study can be found at www.ClinicalTrials.gov, ref: NCT02351024.</p></div>
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