Instanyl(R) (intranasal fentanyl spray) Sets New Standard in Management of Breakthrough Cancer Pain
– Head to Head Study Confirms Superiority of the New Intranasal Treatment
for Breakthrough Cancer Pain Over OTFC
New data presented today further demonstrate the efficacy of Instanyl in
management of breakthrough cancer pain. The data which were presented at the
6th congress of the European Federation of Chapters of the International
Association for the Study of Pain (EFIC) are from a multinational, crossover
trial comparing Instanyl with oral transmucosal fentanyl citrate (OTFC) for
the treatment of breakthrough pain in patients with cancer. The study
concludes that pain relief was significantly greater for Instanyl compared to
OTFC at all time points:
- 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 )
“These data confirm the superiority of the intranasal drug administration
over OTFC. Rapid pain relief is essential for the management of breakthrough
cancer 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,” said
Professor
study and Director of the Anesthesia and Intensive Care and Pain Relief and
Palliative Care Units at La Maddalena Cancer Center, Palermo,
The study also showed that patients found Instanyl significantly easier
to administer than OTFC, with 90% of patients finding Instanyl ‘easy’ or
‘very easy’ to use, compared to 40% of OTFC patients.[2] Instanyl is the
First intranasal treatment for breakthrough cancer pain to be licensed and
The study showed that 77% of patients preferred Instanyl to OTFC.[2]
“With a preference for Instanyl more than three-fold higher compared to
OTFC, the study confirms that with Instanyl patients now have a treatment
that they feel better matches their need,” said Professor Mercadante and
concluded: “Instanyl represents a major step forward in the management of
breakthrough cancer pain.”
Up to 95% of patients with cancer pain experience breakthrough pain,[3]
Of which two-thirds experience inadequate pain control.[4] Interim results
From the first European survey of breakthrough cancer pain[5] also presented
for the first time in
episodes of BTCP per day, each one lasting on average 60 minutes and 96% of
episodes being rated as moderate or severe. 87% of patients reported that
their BTCP interfered with their daily living including their ability to
sleep, 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 these
patients. Time has come for a change in management of breakthrough cancer
pain and with Instanyl now approved we have an intranasal product with fast
onset of pain relief, short duration which is easy to use. This will enable
us to improve the care of cancer patients,” commented President of EFIC,
Professor
L’Aquila University,
Instanyl is approved for the management of breakthrough cancer pain in
adults already receiving maintenance opioid therapy for chronic cancer pain.
This first-in class drug was granted marketing authorisation on the
2009
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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
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About the study
- A multinational, open-label, crossover trial comparing Instanyl(R) and
Actiq(R) for breakthrough cancer pain in patients receiving chronic
opioid treatment.
- The trial investigated the efficacy of Instanyl compared to Actiq as
well as ease of administration and patient preference.
- Primary efficacy measurement was time to onset of meaningful pain
relief.
- Of 196 patients enrolled and 139 randomised, 86 patients completed the
trial.
Results showed that:
- 25.3% of episodes showed meaningful pain relief (greater than or equal
to 33% reduction in PI score) at 5 minutes after treatment with
Instanyl versus 6.8% with Actiq.
- 51% of the Instanyl treated patients had a meaningful pain relief
(greater than or equal to 33% reduction in PI score) at 10 minutes
versus 23.6% with Actiq.
- 90% of patients found Instanyl was 'easy' or 'very easy' to use versus
40% for Actiq.
- 77% of patients preferred Instanyl to Actiq.
- Both treatments were well tolerated with adverse events experienced
being those typical for this group of opioid drugs.
References
1. Mercadante S, Radbruch L, Popper L, Korsholm L, Davies A; Efficacy of
intranasal fentanyl spray (INFS) versus oral transmucosal fentanyl citrate
(OTFC) for breakthrough cancer pain: an open-label crossover trial. Abstract
presented at EFIC 2009.
2. Mercadante S, Radbruch L, Popper L, Korsholm L, Davies A; Ease of use
and preference for intranasal fentanyl spray (INFS) versus oral transmucosal
fentanyl citrate (OTFC) for breakthrough cancer pain. Abstract presented at
EFIC 2009.
3. Zeppetella G. Ribeiro MD. Pharmacotherapy of cancer-related episodic
pain. Expert Opin. Pharmacother. 2003;4:493-502
4. Davis MP, Walsh D, Lagman R, LeGrand SB. Controversies in
pharmacotherapy of pain management. Lancet Oncol. 2005;6:696-704.
5. Davies A, Zeppetella G, Sjoland K-F et al. European Survey of
Breakthrough Cancer Pain. Poster presented at EFIC 2009.
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