Janssen-Cilag, a UK-based member of the Johnson & Johnson family of companies, says that its anti-epileptic agent Topamax (topirimate) is now available for the prevention of migraine. The drug gained US clearance for this indication last year, having already received the regulatory nod in 22 countries at this time [[13/08/04f]]. However, despite its effectiveness, currently only about one in five of eligible patients receives prophylactic therapy, and treatment initiation with the agent is restricted to specialists.
Pivotal study data presented during the recent European Federation of Neurological Societies meeting, held in Athens, Greece, showed that patients treated for up to 14 months with the recommended dose of 50mg twice a day had a persistent reduction in the frequency of migraine headaches. In addition, three 26-week, placebo-controlled, pivotal trials of the agent in migraine prevention revealed that Topamax improves health-related quality of life. Furthermore, more than twice as many taking the agent significantly reduced the number of monthly migraines compared with patients on placebo, and the average duration of migraine was also reduced.
According to the World Health Organisation, migraine represents one of the top 20 leading causes of disability worldwide, affecting around 11% of the adult population in the Western world. Therefore, J&J will be hoping that this latest set of encouraging data will boost the drug’s reputation and, consequently, its sales.