Nycomed's Instanyl® is first intranasal fentanyl approved in Europe

NycomedNycomed announced that the European Commission has granted marketing authorisation for Instanyl®, its first-in-class intranasal fentanyl spray. Instanyl is aimed at managing breakthrough pain in adult cancer patients already receiving maintenance opioid therapy for chronic pain. It is designed to closely match the typical episodes of breakthrough cancer pain. Nycomed plans to launch the product in 2009.

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 cancer pain has a profound impact on patients' quality of life.

Instanyl is an intranasally applied fentanyl spray that has been developed by Nycomed. It is the first fast acting nasal opioid approved for the management of breakthrough cancer pain. The approval of Instanyl is based on a comprehensive data package demonstrating the efficacy and good tolerance of this novel treatment.

"We have had a great unmet need in the management of breakthrough cancer pain. With Instanyl, however, we now have a treatment designed to better meet the needs of a patient suffering from breakthrough cancer pain. Instanyl has a fast onset, a short duration, is well tolerated and is easy to use allowing the patients effective control of the pain episodes with minor adverse effects," said Professor Stein Kaasa from Trondheim University Hospital in Norway and Chairman of the Research Network of the European Association for Palliative Care (EAPC-RN).

Kaasa continued: “Instanyl data presented at the 11th Congress of the European Association for Palliative Care in May in Vienna, and fully published soon, demonstrated an onset of pain relief as early as five minutes underlining the clinical benefit this treatment represents to the patients."

Guido Oelkers, Nycomed's Executive Vice President Commercial Operations added: "Instanyl underlines Nycomed's commitment to therapies with clear medical utility. We strongly believe that this product will provide an innovative approach for the half a million patients with cancer suffering from breakthrough pain in Europe."

About Nycomed
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio. Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy.

Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.

Headquartered in Zurich, Switzerland, the company generated total sales of € 3.4 billion in 2008 and an adjusted EBITDA of € 1.2 billion.

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