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CeNeS Pharmaceuticals plc: Update on Successful Phase III results,announced on Lead Product M6G

ive pain. A limitation of morphine treatment is often the unpleasant side effects experienced, of which nausea and vomiting are the most common. PONV is rated among patients as one of the most distressing after-effects of surgery and reduces their quality of life.

M6G's lower propensity to cause nausea and vomiting in the post-operative period strongly supports CeNeS' belief in the potential of M6G as a novel product for the treatment of post-operative pain with clear advantages over morphine.

3. Safety profile/adverse events

The trial confirmed that M6G's safety profile is similar to morphine. Aside from nausea and vomiting, the adverse events reported were at levels similar to those experienced by patients receiving morphine in a post-operative setting.

M6G022 Study Design The study involved 24 centres in six European countries and recruited 517 patients. The study was designed primarily to provide key information on a comparison of effective intravenous pain management regimens of M6G or morphine treatment for a minimum of 24 hours (and up to 48 hours) following major abdominal surgery. Morphine is generally accepted as the "gold standard" drug for use in these circumstances. Initial pain management was achieved by administration of a loading dose and titration of either M6G or morphine to achieve acceptably low levels of pain for the patient to go onto the ward. In the ward, pain management treatment was achieved by patient controlled analgesia (PCA), whereby the patient was allowed to self administer a dose of M6G or morphine as required to control their pain. The study was randomised and double blind so that neither patient nor carer was aware of which treatment was being administered. The main purpose of the study was to demonstrate statistically that:

- Treatment with either M6G or morphine, particularly during PCA, results in similar levels of pain management; and

- Effective analgesic treatment during PCA results i
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