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Home Industry News Orion provides dexmedetomidine trial update

Orion provides dexmedetomidine trial update

16th September 2008

has given an update to its progress with the ongoing phase III trials of dexmedetomidine for use as a sedative for patients in intensive care.

The company said the programme – which started in summer 2007 – was originally to last two years, but the recruitment of patients has been slower than originally forecast.

It added it will also take longer to complete the studies than originally projected, with Orion now estimating the availability of preliminary results from the trial in summer 2010.

Orion claims a marketing authorisation submission could be made by the end of 2010.

The company hopes to have the product registered in Europe as a long-term infusion administered for over 24 hours.

“Dexmedetomidine is a proprietary medicinal substance originating from Orion’s own alpha 2 receptor research,” the firm said.

It added that the drug is already available in the US and Japan under the Precedex brand name, though it is approved as an infusion for a maximum of 24 hours.

Last month, Orion announced its financial results for the first half of the 2008 financial year, with the company reporting a 4.8 per cent rise in net sales for the period to 362.3 million euros (297 million pounds).

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