Further analysis of Phase III trial data underlines M6G's benefit compared to morphine in the treatment of post-operative pain
CAMBRIDGE, England, 7th March 2007 - CeNeS Pharmaceuticals plc (AIM: CEN), the Cambridge based biopharmaceutical company today announces additional data from the pivotal Phase III trial (M6G022) of M6G (morphine-6-glucuronide) in over 500 patients with post-operative pain. The preliminary data released on 20th February showed that M6G provided equivalent pain relief to morphine but induced significantly less post-operative nausea and vomiting (PONV).
Secondary Data Results
The additional secondary data now received by CeNeS shows that:
* less anti-emetic drugs (drugs used to control nausea and vomiting) were required in patients treated with M6G compared with those on morphine; and * M6G exhibited a long duration of analgesic action.
This was the first Phase III study where patients were given a complete pain management programme with M6G (rapid titration to comfort followed by PCA for up to 48 hours) and the first Phase III trial where nausea and vomiting were assessed as primary endpoints.
Management of PONV/use of anti-emetics
In addition to the clear nausea and vomiting reductions of over 25% announced last week, secondary data reveals 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.
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