TRONDHEIM, Norway, May 29 /PRNewswire/ --

- Randomised Double-Blind Trial Results Show Meaningful Pain Relief at 10 Minutes in Patients With Breakthrough Cancer Pain

- Treatment Aimed at Opioid-Tolerant Patients With Cancer Experiencing Breakthrough Pain

- New and Easy to Administer Analgesic Formulation Designed to Provide Fast Patient Benefit

Meaningful pain relief at 10 minutes following dosing with intranasal fentanyl spray among patients with cancer who experience breakthrough pain was reported today at the Fifth Research Forum of the European Association for Palliative Care, in Trondheim, Norway.(1) All patients involved in the trial were already receiving effective treatment to control background pain, but still experienced episodes of breakthrough pain every day.

Intranasal fentanyl spray is aimed at managing breakthrough pain in adult patients with cancer who are already receiving maintenance opioid therapy for their background pain. Breakthrough pain is a transitory exacerbation of pain experienced by the patient who has relatively stable and adequately controlled background pain. A typical breakthrough pain episode has a fast onset, is often severe, with an average duration of 30 minutes and about 90% having less than one hour duration. Consequently, an analgesic formulation matching such a fast onset and short duration would provide an ideal treatment and tight control of the breakthrough pain episode.

In all, 159 patients were included in the trial, who were given unmarked sprays delivering placebo or three different dose strengths of intranasal fentanyl which they were to use immediately when they experienced the onset of breakthrough pain. Meaningful pain relief was reported at 10 minutes after dosing in 29%, 42%, and 50% of patients taking doses of 50, 100, or 200 (micro)g of intranasal fentanyl, compared with 22% for placebo. 'Patients used three different doses of intranasal fentanyl, or placebo, to treat their breakthrough pain, in a completely random manner,' said Professor Stein Kaasa, of St Olav's Hospital and Institute of Cancer Research and Molecular Medicine, NTNU, Norway, who presented the results of the study, 'and there was significant reduction in pain intensity for all doses of intranasal fentanyl compared with using placebo.'

Dr Thomas Nolte, of the Pain and Palliative Care Centre (Schmerz- und Palliativzentrum), Wiesbaden, Germany, who led the team of investigators conducting the trial which involved patients from a number of countries in Europe, also commented on the study, stating: 'These results suggest that the intranasal fentanyl spray is a very promising treatment for breakthrough pain in patients with cancer. It is also easy to use, which means patients can be more independent, knowing they can simply administer their own analgesia and gain fast relief from their pain.'

About Breakthrough Pain

The prevalence of patients with cancer in Europe is approximately 2.9 million.(2) Over 80% of patients with cancer experience pain, in later stage disease, and approximately two-thirds of these experience breakthrough pain.(3-5) Breakthrough pain is a transitory exacerbation of pain experienced by the patient who has relatively stable and adequately controlled baseline pain.(6) The typical breakthrough pain episode is characterised by a fast onset, is severe, usually reaching a peak of intensity within three minutes, with an average duration of approximately 30 minutes. About 90% of the episodes have a duration of less than one hour.(2-4) Cancer patients can experience breakthrough pain several times per day, (3-5,7) which may significantly impact the patient's life.

Health care professionals can find out more about breakthrough pain at:

Nycomed does not provide information directly to patients. Patients should always consult their physician.

About Nycomed

Nycomed is a pharmaceutical company that provides medicines for hospitals, specialists and general practitioners, as well as over-the-counter medicines in selected markets.

Nycomed has an established presence in pain control and several products in its research and development pipeline. With the introduction of the intranasal fentanyl spray, Nycomed will provide products to manage both background and breakthrough pain for patients with cancer, confirming their strong commitment to the pain control therapy area. At present Nycomed's intranasal fentanyl spray is not approved by any regulatory authority for any indication and is currently under evaluation. Nycomed filed a marketing authorisation application with the European Medicines Agency (EMEA) for the intranasal fentanyl spray in Europe on 7 December 2007.

The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced from their own research and from external partners. Operating throughout Europe and in fast growing markets such as Latin America, Russia/CIS and the Asia/Pacific region, Nycomed has a presence in about 50 markets worldwide.

Privately owned, the combined group had annual sales of approximately Euro 3.4 billion and an EBITDA of Euro 933.4 million (2006 results).

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Note for editors:

A background document focusing on breakthrough pain in patients with cancer is available on request. Please contact Ulf Jonson (contact above).


(1). Kaasa S. A randomised, double-blind, placebo-controlled, cross-over, multi-centre trial to evaluate the efficacy of intranasal fentanyl for breakthrough pain in cancer patients. Presented at the Fifth Research Forum of the European Association for Palliative Care, in Trondheim, Norway, 29-31 May 2008. Abstract No 41


(3). Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence, and characteristics. Pain 1990;41:273-281

(4). Zeppetella G, O'Doherty CA, Collins S. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. Journal of Pain and Symptom Management 2000;20:87-92

(5). Gómez-Batiste X, Madrid F, Moreno F, Gracia A, Trelis J, Nabal M, Alcalde R, Planas J, Camell H. Breakthrough cancer pain: prevalence and characteristics in patients in Catalonia, Spain. Journal of Pain and Symptom Management 2002;24:45-52

(6). Portenoy, RK, Forbes K, Lussier D, Hanks G. Difficult pain problems: an integrated approach. In Oxford Textbook of Palliative Medicine, 3rd edition (2004). Oxford University Press, 438-458

(7). Zeppetella G, Ribeiro MD. Pharmacotherapy of cancer-related episodic pain. Expert Opinion on Pharmacotherapy 2003;4:493-502

For further information: Media: Tobias Cottmann, Director of External Communications, Tel: +21-44-55-515-10; Medical, professional, and scientific media: Ulf Jonson, International Product Manager, Tel: +45-4677-10-78