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

wn that M6G given intravenously produces equivalent analgesia to morphine to combat post-operative pain. Studies have also shown that M6G reduced the incidence of nausea and vomiting when compared directly with morphine. Other studies published recently in the scientific literature demonstrate that M6G also reduces respiratory depression compared to morphine.

The global market for opiate use in managing post-operative pain was estimated at $1 billion in 2000 and growing at a rate of 6-7%.

Summary of Phase III trial (M6G022) results

1. M6G matches morphine for analgesic effect

Importantly for a novel pain product, the trial results unequivocally show that M6G is as good as morphine in terms of analgesia achieved in patients up to 48 hours post-operatively. Successful achievement of this first primary endpoint supports data from previous clinical trials of M6G and is an essential component in the product profile of M6G.

2. M6G shows significant reduction in post-operative nausea and vomiting compared to morphine

The trial results confirm the excellent potential of M6G as an analgesic with a clinically significant improved side effect profile compared to morphine. The study results show that patients receiving M6G experienced a 28% reduction in the severity of post-operative nausea and vomiting (PONV) in the key 6 - 24 hours after treatment (statistically significant, p=0.018).

In addition, the incidence of dry retching/vomiting in the M6G arm compared to the morphine arm in the 24 hour period after treatment was reduced by 32% ( statistically significant, p= 0.044). The incidence and severity of post-operative nausea in the M6G arm was 27% less than that observed 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-operat
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