Scottish Medicines Consortium (SMC) Approves Topamax(R) For Prevention Of Migraine

Main Category: Headache / Migraine
Article Date: 14 Sep 2006 - 0:00 PDT


A significant new treatment option to prevent migraine headaches is now available in Scotland following Monday's approval of TOPAMAX(R) (topiramate) by The Scottish Medicines Consortium (SMC)1.

Unlike acute medicines that are taken at the onset of a migraine, daily migraine preventative therapy can reduce the risk of migraine occurrence. British Association for the Study of Headache (BASH) guidelines recommend that prophylaxis is used to reduce the number of attacks in circumstances when acute therapy, used appropriately, gives inadequate symptom control.2

Dr Alok Tyagi, consultant Neurologist at the Southern General Hospital in Glasgow, welcomed the SMC's approval, "This is good news for migraine sufferers across Scotland. Topamax is an important addition to the current therapies for managing migraine and will provide relief for many sufferers from the strain of living with this condition."

Migraine is a very common disorder which affects around 11% of the adult population in the Western world.3 One UK study estimates that 5.85 million people in the UK aged 16-65 years experience 190,000 migraine attacks every day and lose 25 million days from work each year, because of them.4

The approval of TOPAMAX(R) for migraine prevention was based on the largest-ever migraine prevention trial programme that consisted of three studies involving more than 1,500 patients.5,6,7 In clinical studies, patients treated with 100mg of TOPAMAX(R) a day experienced a significantly greater reduction in monthly migraine attacks than the group taking placebo.5,6,7 Nearly half of the patients on the 100mg dose of TOPAMAX(R) had a greater than 50 percent reduction in migraine frequency, while over a quarter of patients experienced a greater than 75 percent reduction in migraine frequency.8

TOPAMAX is approved in the UK as a treatment for epilepsy. More recently, TOPAMAX(R) has been approved for migraine prophylaxis in 41 countries.

In Scotland, the SMC has approved TOPAMAX(R) for the prophylaxis of migraine headache in adults who have not responded to prophylactic treatment with at least one other agent. Initiation of treatment should be restricted to specialist care and treatment should be managed under specialist supervision or shared care arrangements. 1,9

In patients taking TOPAMAX(R) at the target dose (100mg/day in two divided doses), the most common adverse events seen were paraesthesia, fatigue, anorexia, upper respiratory tract infection, nausea and diarrhoea. Most adverse events were mild to moderate and usually led to withdrawal in less than 3% of patients, with the exception of parasthesia, fatigue and insomnia7. A full list of adverse events seen with TOPAMAX(R), is included in the Summary of Product Characteristics. 9

Janssen-Cilag Ltd market prescription medicines in several therapeutic areas including analgesia, neurology, psychiatry, gastroenterology, oncology and women's health. Janssen-Cilag Ltd is a part of the Johnson & Johnson family of companies, the world's most comprehensive manufacturer of healthcare products. More information about the company can be found at http://www.janssen-cilag.co.uk.

References
1. http://www.scottishmedicines.org.uk
2. BASH Management Guidelines 2004. http://www.bash.org.uk
3. Lipton RB, Stewart WF, Scher AI. Epidemiology and economic impact of migraine. Curr Med Res Opin 2001; 17 (Suppl 1): S4-S12.
4. Steiner TJ, et al. The prevalence and disability burden of adult migraine in England and their relationships to age, gender and ethnicity. Cephalalgia, 2003, 23, 519 -527
5. Silberstein SD, et al. Topiramate in Migraine Prevention: Results of a Large Controlled Trial. Arch Neurol. 2004; 61:490-495
6. Brandes JL, et al. Topiramate for Migraine Prevention: A randomised Controlled Trial. JAMA 2004; 291:965-973
7. Diener H-C, et al. Topiramate in migraine prophylaxis; Results from a placebo-controlled trial with propranol as an active control. J Neurol 2004; 251: 943-950
8. Bussone G, Diener H C, Pfeil J et al. Topiramate 100mg/day in migraine prevention: a pooled analysis of double blind randomised controlled trials. Int J Clin Pract 2005; 59 (8): 961 968.
9. Topamax Summary of Product Characteristics

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