Nycomed's Instanyl® receives positive CHMP opinion

NycomedNycomed's Instanyl (intranasal fentanyl spray) received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), recommending the granting of a marketing authorisation. Instanyl is aimed at managing breakthrough pain in adult cancer patients already receiving maintenance opioid therapy for chronic pain. If approved, Nycomed intends to launch the product in 2009.

Nearly half of all early-stage cancer patients with chronic pain and up to 90 percent in later stages suffer the sudden onset of brief but acute 'breakthrough' pain. This refers to intermittent flare-ups that overcome the patient's regular pain medication. The unpredictability and severity of these attacks can have a highly deleterious effect on the quality of life.

Instanyl is an intranasally applied fentanyl spray that has been developed by Nycomed. It is intended for managing breakthrough pain in adult cancer patients who are already receiving maintenance opioid therapy for chronic pain.

"With Instanyl, we want to offer patients a new treatment principle that offers tight control of the breakthrough pain in cancer. What matters for patients with this type of repeated episodes of severe pain is a rapid onset of action and duration of the effect not longer than necessary", explained Anders Ullman, Executive Vice President Research and Development at Nycomed.

The complete summary of the positive CHMP opinion can be downloaded at the EMEA website:

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 built to be open for partnerships as 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 will further strengthen its position in key Asian markets.

Headquartered in Zurich, Switzerland, the company generated in 2008 total sales of € 3,4 billion and an adjusted EBITDA of € 1,2 billion.

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