Abstral® is an important new treatment option for inadequately controlled breakthrough cancer pain (BTcP) in opioid-tolerant cancer patients. The Abstral formulation delivers the analgesic power of fentanyl in a fast dissolving sublingual tablet. Abstral provides rapid relief of BTcP from 10 minutes1, provides predictable dosing2,3 and is convenient and easy to use.
“Breakthrough cancer pain is a common problem, which despite being self-limiting has significant physical, psychological, social and economic consequences. The relatively fast onset and short duration of most breakthrough pains makes its management with oral opioids far from ideal. The development of transmucosal opioid formulations that are safe and effective, and provide pain relief in a time frame consistent with the rapid time course of most breakthrough pains is an exciting prospect.” Dr G Zeppetella FRCP. Consultant in Palliative Medicine and Medical Director, St Clare Hospice.
Fentanyl is a “fast-in, fast-out” drug4. Abstral has pharmacokinetics that match the profile of breakthrough pain. Formulated as rapidly disintegrating muco-adhesive sublingual tablets, Abstral is highly lipophillic5 with the Fentanyl dissolving almost instantly from the tablets6. It is highly potent7,8, crossing the blood-brain barrier rapidly in both directions4, avoiding first-pass metabolism by the liver enzymes,9,10,11 and offering approx 70% bioavailability12.
Abstral is convenient and easy to use, dissolving under the tongue within seconds6. Abstral’s innovative technology means it requires less than 1ml of fluid to dissolve.
“Currently most patients with breakthrough pain are prescribed oral morphine, which is invariably an inappropriate treatment due to its slow onset of action, and its prolonged duration of effect. The slow onset of action leads to poor efficacy, whilst the prolonged duration of effect leads to poor tolerability”. Dr Andrew Davies FRCP, Consultant in Palliative Medicine, Royal Marsden Hospital (Surrey)
Breakthrough cancer pain is a transitory exacerbation of pain experienced by patients who have relatively stable and adequately controlled background pain13 and affects 40-80% of patients14. BTcP strikes very quickly and without warning in many cases peaking in as little as three minutes15,17 and lasting on average for 30 minutes15,16. Untreated BTcP can significantly reduce quality of life for patients, increasing functional impairment, depression, anxiety and psychological distress17 As a consequence untreated BTcP is associated with increased use of healthcare resources and medical costs18.
Research shows that conventional oral opioids do not match the temporal characteristics of breakthrough cancer pain 9,16 and may not start working until the episode of pain has resolved19. Data has shown that there are significant improvements in pain intensity difference (PID) from 10 minutes (p=0.0055) with Abstral vs. placebo and these improvements in PID are maintained for 60 minutes1.
Abstral is well tolerated20 (in clinical trials most adverse events were mild or moderate in severity) and side effects are typical of the opioid class and consistent with the known pharmacology of fentanyl 20. Studies also highlighted that Fentanyl causes less constipation and drowsiness than morphine21.
Abstral is available as: 100 microgram, 200 microgram, 300 microgram, 400 microgram, 600 microgram and 800 microgram sublingual tablets.
ProStrakan Group plc is a rapidly growing speciality pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets. The Company’s development facilities are situated at ProStrakan’s headquarters in Galashiels in Scotland. EU-wide sales and marketing of ProStrakan’s portfolio of products are handled by commercial subsidiaries in the UK, France, Germany, Spain and other EU countries. http://www.prostrakan.com
Black Triangle Products
Black triangle products are new drugs and vaccines which are being monitored in order to confirm the risk/benefit profile of the product. A black triangle symbol indicates that the CHM and MHRA are intensively monitoring that product. A black triangle is assigned to a product if the drug is a new active substance. However, a product containing previously licensed active substances may also be monitored if it meets one or more of the following criteria:
- a new combination of active substances;
- administration via a new route of administration or drug delivery system; or
- a significant new indication which may alter the established risk/benefit profile of that drug
There is no standard time for a product to retain black triangle status. However, an assessment is usually made following two years of post-marketing experience and the black triangle symbol is not removed until the safety of the drug is well established.
1. Data on file – Study EN3267-005
2. Lennernäs et al. Br J lin Pharmacol 2005; 59(2): 249-253
3. Data on file, 2006 – Study 2246-EU-005
4. Taylor DR. Medscape Neurol Neurosurg 2005: 7(2) (Posted 13/12/05)
5. Simmonds MA. Oncology 1999; 13: 1103-1108
6. Bredenberg S et al. Eur J Pharm Sci 203; 20: 327-334
7. Dollery C.Therapeutic Drugs, Second Edition. 1999. Churchill Livingston, London
8. Lichtor JL et al. Anesth Anaig 1999, 89: 732-738
9. Davies A (ed.) Cancer-Related Breakthrough Pain, Oxford University Press 2006
10. McMenamin E, Farrar JT. Expert Rev Neurotherapeutics 2002; 2(5): 625-629
11. Weinberg DS et al. Clin Pharmacol Ther 1988; 44: 335-342
12. Abstral Summary of Product Characteristics, June 2008
13. Portenoy RK et al. In: Doyle D, Hanks G, Cherny N, Calman K, ed. Oxford Textbook of Palliative Medicine (3rd edn), 2003. Oxford University Press, Oxford, 438-458
14. Mercadante S et al. Cancer 2002; 94: 832-839
15. Portenoy RK, Hagan NA Pain 1990; 41: 273-281
16. Davies AN et al. J Pain Symptom Manage 2008; 35(4): 406-411
17. Portenoy RK, Payne D, Jacobsen P.Pain 1999, 81: 129-134
18. Fortner BV et al. J Pain 2002; 3(1): 38-44
19. Zeppetella G. J Pain Symptom Manage 2008; 35(5): 563-567
20. Data on file – Study SuF-002
21. Palliative medicine handbook, 2001, Alternative strong opioids, (online) Available at http://book.pallcare.info/index.php?tid=27 (Accessed: 13th October 2008)