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Instanyl(R) (intranasal fentanyl spray) Sets New Standard in Management of Breakthrough Cancer Pain

Thursday, September 17, 2009 General News J E 4
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LISBON, Portugal, September 11

- Head to Head Study Confirms Superiority of the New Intranasal Treatmentfor Breakthrough Cancer Pain Over OTFC

New data presented today further demonstrate the efficacy of Instanyl inmanagement of breakthrough cancer pain. The data which were presented at the6th congress of the European Federation of Chapters of the InternationalAssociation for the Study of Pain (EFIC) are from a multinational, crossovertrial comparing Instanyl with oral transmucosal fentanyl citrate (OTFC) forthe treatment of breakthrough pain in patients with cancer. The studyconcludes that pain relief was significantly greater for Instanyl compared toOTFC at all time points:

"These data confirm the superiority of the intranasal drug administrationover OTFC. Rapid pain relief is essential for the management of breakthroughcancer pain and with evidence of onset of pain relief as early as 5 minutes,Instanyl offers patients a much more effective pain control than OTFC," saidProfessor Sebastiano Mercadante, principal investigator of the comparativestudy and Director of the Anesthesia and Intensive Care and Pain Relief andPalliative Care Units at La Maddalena Cancer Center, Palermo, Italy.

The study also showed that patients found Instanyl significantly easierto administer than OTFC, with 90% of patients finding Instanyl 'easy' or'very easy' to use, compared to 40% of OTFC patients.[2] Instanyl is theFirst intranasal treatment for breakthrough cancer pain to be licensed andThe study showed that 77% of patients preferred Instanyl to OTFC.[2]

"With a preference for Instanyl more than three-fold higher compared toOTFC, the study confirms that with Instanyl patients now have a treatmentthat they feel better matches their need," said Professor Mercadante andconcluded: "Instanyl represents a major step forward in the management ofbreakthrough cancer pain."

Up to 95% of patients with cancer pain experience breakthrough pain,[3]Of which two-thirds experience inadequate pain control.[4] Interim resultsFrom the first European survey of breakthrough cancer pain[5] also presentedfor the first time in Lisbon show that on average a patient will have 3episodes of BTCP per day, each one lasting on average 60 minutes and 96% ofepisodes being rated as moderate or severe. 87% of patients reported thattheir BTCP interfered with their daily living including their ability tosleep, walk and get on with other people.

"Breakthrough cancer pain afflicts a large proportion of cancer patients,yet there is a significant under-treatment and sub-optimal treatment of thesepatients. Time has come for a change in management of breakthrough cancerpain and with Instanyl now approved we have an intranasal product with fastonset of pain relief, short duration which is easy to use. This will enableus to improve the care of cancer patients," commented President of EFIC,Professor Giustino Varrassi, Dept. of Anesthesiology and Pain MedicineL'Aquila University, Italy.

Instanyl is approved for the management of breakthrough cancer pain inadults already receiving maintenance opioid therapy for chronic cancer pain.This first-in class drug was granted marketing authorisation on the 20th July2009, and will be launched across Europe from September 2009.

About Nycomed

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

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

Headquartered in Zurich, Switzerland, the company generated total salesof EUR3.4 billion in 2008 and an adjusted EBITDA of EUR1.2 billion.

References

1. Mercadante S, Radbruch L, Popper L, Korsholm L, Davies A; Efficacy ofintranasal fentanyl spray (INFS) versus oral transmucosal fentanyl citrate(OTFC) for breakthrough cancer pain: an open-label crossover trial. Abstractpresented at EFIC 2009.

2. Mercadante S, Radbruch L, Popper L, Korsholm L, Davies A; Ease of useand preference for intranasal fentanyl spray (INFS) versus oral transmucosalfentanyl citrate (OTFC) for breakthrough cancer pain. Abstract presented atEFIC 2009.

3. Zeppetella G. Ribeiro MD. Pharmacotherapy of cancer-related episodicpain. Expert Opin. Pharmacother. 2003;4:493-502

4. Davis MP, Walsh D, Lagman R, LeGrand SB. Controversies inpharmacotherapy of pain management. Lancet Oncol. 2005;6:696-704.

5. Davies A, Zeppetella G, Sjoland K-F et al. European Survey ofBreakthrough Cancer Pain. Poster presented at EFIC 2009.

For further information:

Media: Ulf Jonson, Senior International Brand Manager, Nycomed:+45-46-77-10-78- 25% of episodes showed meaningful pain relief already at 5 minutes after treatment with Instanyl, as compared to 7% with OTFC. (p<0.001)[1] - 51% of the Instanyl treated patients had a meaningful pain relief at 10 minutes, as compared to 24% with OTFC. (p<0.001)[1] (Logo: http://www.newscom.com/cgi-bin/prnh/20090909/358726 )

SOURCE Nycomed
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