TAASTRUP, Denmark, July 24 --
- First Intranasal Treatment for Breakthrough Cancer Pain Allowing Patients
Fast, Effective and Good Tolerated Pain Relief Soon to be Available
Nycomed today announced that the European Commission has granted marketing
authorisation for Instanyl, its first-in-class intranasal fentanyl spray
designed to closely match the typical episodes of breakthrough cancer pain.
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
Instanyl is the first fast acting intranasal fentanyl spray approved for the
management of breakthrough cancer pain in adults already receiving maintenance
opioid therapy for chronic cancer pain. The approval of Instanyl is based on
comprehensive data demonstrating the efficacy and good tolerance of this novel
treatment. Phase III data[i] on Instanyl has shown:
- clinically substantial pain relief at 10 minutes after administration in 58%
of Instanyl treated pain episodes (P0.001) - all doses of Instanyl were well
tolerated during the 10-month follow-up phase
The intranasal drug administration is an innovation within treatment of
breakthrough cancer pain. The rapid uptake via the nose translates into fast
onset of action enabling the patients to be in control of their pain. Instanyl
data presented at the 11th Congress of the European Association for Palliative
Care (EAPC) 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, said Professor Kaasa.
Breakthrough pain is a transitory exacerbation of pain occurring with
controlled persistent pain. Up to 95% of patients with cancer pain experience
breakthrough pain[ii] of which two-thirds experience inadequate pain
control[iii]. Untreated breakthrough cancer pain has a profound impact on
patients’ quality of life[iv], [v].
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.
Nycomed plans to launch Instanyl in 2009.
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 RD is built to be open for partnerships as in-licensing is a cornerstone in
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 euro 3.4 billion and an adjusted EBITDA of euro 1.2 billion.
For more information please visit http://www.nycomed.com
[i] Kress. H. G. et al. Efficacy and Tolerability of Intranasal Fentanyl Spray
50 to 200Î¼g for Breakthrough Pain in Patients With Cancer: A Phase III,
Multinational, Double-Blind, Randomized, Placebo-Controlled, Crossover Trial
With a 10/Month, Open-Label Extension Treatment Period. Clin Ther. 2009;31:
[ii] Zeppetella G. Ribeiro MD. Pharmacotherapy of cancer-related episodic pain.
Expert Opin. Pharmacother. 2003;4:493-502
[iii] Davis MP, Walsh D, Lagman R, LeGrand SB. Controversies in pharmacotherapy
of pain management. Lancent Oncol. 2005;6:696-704.
[iv] Hwang SS, Chang VT, Kasimis B. Cancer breakthrough pain characteristics
and responses to treatment at a VA medical center. Pain. 2003;101:55-64.
[v] Portenoy RK, Payne D, Jacobsen P. Breakthrough pain: characteristics and
impact in patients with cancer pain. Pain. 1999.;81:129-34.
For further information
Media: Ulf Jonson, Senior International Brand Manager, Nycomed: +45-46-77-10-78
For further information: Media: Ulf Jonson, Senior International Brand Manager,