Nycomed’s Instanyl® (fentanyl) single-dose nasal spray receives European approval



  • European Commission grants marketing authorisation for Nycomed's Instanyl® single-dose nasal spray for treatment of breakthrough pain (BTP) in cancer patients
  • Further extends the successful range of Instanyl® nasal applications
  • Provides patient-friendly, cost-effective treatment and greater flexibility


Nycomed today announced that the European Commission has granted marketing authorisation for its Instanyl® single-dose nasal spray. The single-dose nasal spray marks another innovation by Nycomed in the management of breakthrough pain in cancer patients and will be available in European countries from September 2011.

Instanyl® fentanyl nasal spray has been developed by Nycomed. It was the first fast acting nasal opioid approved for the management of breakthrough pain in cancer patients, and was first approved in Europe in a multi-dose nasal spray in 2009.

The launch of the single-dose nasal spray will provide greater flexibility to the patient and help to manage dose titration and dose modification, as well as enabling easier tracking of patient’s use of rescue medication.

The single-dose nasal spray will be available in all Instanyl dose strengths, 50 μg, 100 μg, and 200 μg.

Stein Kaasa, Professor at the Norwegian University of Science and Technology, Trondheim (NTNU), said: "Instanyl represents a clear benefit for a large number of cancer patients who suffer from breakthrough pain. The launch of the single-dose nasal spray will ease the
management of dose titration and modification, which together with the nasal spray's safety and convenience should contribute to further improving the management of breakthrough pain."

Guido Oelkers, Executive Vice President at Nycomed, added: "Development of the Instanyl single-dose nasal spray further demonstrates Nycomed's commitment to innovation in areas of clear medical need. Over half a million cancer patients are suffering from breakthrough pain
in Europe. The Instanyl single-dose nasal spray will add flexibility to the managing of their pain."

About Breakthrough Pain (BTP)

Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Up to 95% of patients with cancer pain experience breakthrough pain, of which two-thirds experience inadequate pain control. Untreated breakthrough pain has a profound impact on patients' quality of life.

About Nycomed

Nycomed is a privately owned global pharmaceutical company with a diversified portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. A range of OTC products completes the portfolio.
Its R&D is structured around collaborations. In-licensing and expanding in emerging markets are cornerstones of the company's growth strategy.

Nycomed employs 12,500 associates worldwide, and its products are sold in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS, Latin America, Asia and the Middle East. In the US and Japan its products are available
through best in class partners.

Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2010 and an adjusted EBITDA of €851 million.


For further information

General phone:
+41 44 555 15 10
Tobias Cottmann, phone:
+41 44 555 15 01
Christian B. Seidelin, phone:
+41 44 555 11 04

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