Nycomed files marketing authorisation application for an intranasal fentanyl spray in Europe


Marketing authorisation application filed for Europe through the Centralised Procedure

Treatment aimed at opioid tolerant patients with cancer experiencing breakthrough pain

Strengthening the Nycomed pain control portfolio

Nycomed filed a marketing authorisation application with the European Medicines Agency (EMEA) for an intranasal fentanyl spray in Europe on December 7, 2007. It is seeking approval for the indication of managing breakthrough pain (BTP) in adults already receiving maintenance opioid therapy for cancer pain. If approved, the centralised filing could allow Nycomed to be the first to enter the market in 29 European countries with an intranasally administered formulation of fentanyl.

Intranasal fentanyl is aimed at managing breakthrough pain in adult cancer patients already receiving maintenance opioid therapy for chronic pain. Breakthrough pain is a transitory exacerbation of pain experienced by the patient who has relatively stable and adequately controlled baseline pain. The onset of breakthrough pain is sudden. It peaks in less than three minutes and usually lasts for no longer than 30 minutes in total.

“We are aiming for a product profile of the intranasal fentanyl spray that provides patients with a rapid onset of action and adequate short duration, closely matching the typical breakthrough pain episode. We want to offer a clear medical utility through tight control of the breakthrough pain”, explained Anders Ullman, Executive Vice President Research and Development. “It is a significant medical milestone marking progress in the treatment of breakthrough pain”, added Dick Söderberg, Executive Vice President International Marketing.

Nycomed has an established presence in pain control and several pain products in its Research and Development Pipeline. With the introduction of the intranasal fentanyl spray, Nycomed would provide products to manage both background and breakthrough pain for patients with cancer, confirming their strong commitment to the pain control arena.

Nycomed’s intranasal fentanyl application is not approved by any regulatory authority for any indication and is currently being evaluated.

About Breakthrough Pain

The prevalence of patients with cancer in Europe is approximately 2.9 million.1 Over 80% of patients with cancer experience pain, in later stage disease, and approximately two-thirds of these experience breakthrough pain.2-4 Breakthrough pain is a transitory exacerbation of pain experienced by the patient who has relatively stable and adequately controlled baseline pain.5 The typical breakthrough pain episode is characterised by a fast onset, is often very 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 People can experience breakthrough pain several times per day.2–4,6 Breakthrough pain may significantly impact the patient’s life.

Healthcare professionals can find more information 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.

The company is active within a range of therapeutic areas, including cardiology, gastroenterology, osteoporosis, respiratory, pain and tissue management. New products are sourced both from 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 € 3.4 billion and an EBITDA of € 933.4 million (2006 results).

For more information visit

For further information
Tobias Cottmann, Director External Communications
Phone +41 44 55-515 10

Medical professionals and scientific media:
Ulf Jonson, International Product Manager
Phone +45 4677 10 78


Notes for editors

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

Healthcare professionals can find more information about breakthrough pain at



2. Portenoy R, Hagen NA. Breakthrough pain; definition, prevalence, and characteristics. Pain 1990;41:273–281

3. 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

4. Gómez-Batiste X, Madrid F, Moreno F, Gracia A, Treli 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

5. 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

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

7. Twycross R, Wilcock A, Thorp S. Palliative care formulary. 1998. Radcliffe Medical Press Ltd., Abingdon

8. Mercadante S, Radbruch L, Carceni, A, et al. Episodic (breakthrough) pain. Consensus conference of an expert working group of the European Association for Palliative Care. Cancer 2202;94:832–39

9. Popper L and Christrup L. Breakthrough pain: a randomized trial comparing nasal and intravenous fentanyl in patients with post operative pain. Abstract and poster presentation. EAPC (Budapest) June 2007.

10. Chaushu G, et al. Salivary Flow and Its Relation with Oral Symptoms in Terminally Ill Patients. Cancer 2000; 88:984–7.

11. Sweeney MP, et al. Oral disease in terminally ill cancer patients with xerostomia. Oral Oncol 1998; 34:123–6.



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Beatrix Benz,

phone: +41 44 555 1508
Tobias Cottmann,

phone: +41 44 555 1501

Christian B. Seidelin,

phone: +41 44 555 11 04

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