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

nt 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 in lower levels of nausea and vomiting in patients receiving M6G compared to those receiving morphine.

In addition, other important side effect, efficacy and safety features were determined throughout the study.

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 observ
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