3/22/2012

Orion's MIDEX and PRODEX results published in JAMA

PRESS RELEASE 22 March 2012 at 15.45 EET

The results of the MIDEX and PRODEX studies of dexmedetomidine were published in the Journal of the American Medical Association (JAMA) on 21 March 2012 (Jakob SM et al. JAMA. 2012;307(11):1151-1160) with associated editorial (Wunsch H. JAMA. 2012;307(11):1195-1197). The studies were sponsored by the Orion Corporation and conducted in 1,000 intensive care patients in more than 10 European countries.

The results of these two randomized trials showed that dexmedetomidine was not inferior to the standard sedatives midazolam and propofol in maintaining light to moderate sedation but was successful in reducing the duration of mechanical ventilation compared with midazolam. In addition dexmedetomidine patients were extubated earlier compared to both propofol and midazolam patients and had improved ability to cooperate and communicate pain compared with the other drugs. Safety findings were consistent with previous data and did not identify any new safety concerns following up to 14 days of treatment with dexmedetomidine.

Professor Jukka Takala, the senior author of the paper and senior scientific advisor of the two trials, says: "Sedation is a major problem in long-stay intensive care patients. The current two trials provide convincing evidence that dexmedetomidine offers an alternative for sedation of patients needing prolonged mechanical ventilation. Dexmedetomidine appears to shorten the time needed for mechanical ventilation and improves communication between the patient and caregiver".

At the time of the publication Orion is participating in the International Symposium on Intensive Care and Emergency Medicine (ISICEM) and on March 21 also held a successful symposium entitled "Dexmedetomidine in the European ICU - the first experiences" where over 400 attendees heard presentations on the experience of dexdor® in Europe.

About dexmedetomidine
Dexmedetomidine is a sedative agent originated by Orion's pharmaceutical R&D. It is a relatively selective alpha2-agonist which acts on the central nervous system to produce sedation. The product is available with the brand name Precedex® in more than 30 countries outside Europe including the USA (since 2000) and Japan (since 2004). The distributor for the product outside Europe is Hospira under Orion's license.

Orion obtained centralised marketing authorisation for dexmedetomidine (dexdor®) for all 27 EU member states in September 2011. The sedative is already available in approximately 15 European countries and will be launched by Orion in most of the remaining countries during this year.

Orion Corporation

Contact person:
Dr. Paula Rytilä, MD, Ph.D., Medical Director, tel. +358 50 966 4416

Additional information:

Please see the article for additional information, including authors, author contributions and affiliations, financial disclosures, etc:

http://jama.ama-assn.org/content/307/11/1151.full?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=MIDhttp://jama.ama-assn.org/content/307/11/1151.full?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=MIDEX+and+PRODEX+&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

The press release from JAMA:

http://pubs.ama-assn.org/media/2012j/0320.dtl#3

About Orion
Orion is a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. Pharmaceutical R&D focuses on central nervous system drugs, oncology and critical care drugs, and Easyhaler® pulmonary drugs.

Orion's net sales in 2011 amounted to EUR 918 million and the company had about 3,400 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.

Orion Press Release 22 March 2012