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Further Statistical Analysis of the Recent Phase III trial on Lead,Product M6G Shows Additional Benefits

ed in the morphine arm in the period 6 - 24 hours after treatment. This was the second primary endpoint and approached statistical significance (p=0.052).

Morphine formulations are the gold standard treatment for the relief of moderate to severe post-operative 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.

4. Management of PONV/use of anti-emetics

Secondary data revealed that patients receiving M6G required over 20% less anti-emetic medication over the 0-24 hour period than those in the morphine group. This shows that not only does M6G induce significantly less nausea and vomiting than morphine, but also that the post-operative anti-emetic treatment required is considerably reduced.

The potential for reduced anti-emetic drug costs combined with the reduction in medical assistance and the improved patient comfort due to lower PONV supports CeNeS' justification of a substantial price premium for M6G compared to morphine.

5. Drug consumption

It has been shown in previous studies that the dose of M6G required to provide analgesia immediately after surgery is three times that of morphine. In accordance with this, the M6G022 trial was designed such that M6G was available in a 3:1 ratio to morphine during the
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