Vernalis confirms frovatriptan highly effective in preventing menstrual migraine

2 April 2003

New US Phase IIIb data presented at the American Academy of Neurology Annual Meeting

Vernalis Group plc (LSE: VER) is pleased to announce that yesterday the key findings from a large multi-centre study demonstrating the benefits of frovatriptan in the prophylaxis (prevention) of menstrually associated migraine (MAM) were presented at the American Academy of Neurology Annual Meeting. These findings confirm the positive results announced by the Company in September 2002 and underline the potential value of this additional indication for frovatriptan.

These data were presented to delegates at the largest neurology meeting in the USA (around 10,000 attendees) by leading migraine expert Dr Stephen Silberstein, Professor of Neurology at the Thomas Jefferson Hospital in Philadelphia, PA. This was the first time the new Phase IIIb data were presented to an international medical audience.

More than 500 menstrual migraine sufferers participated in the double-blind placebo controlled crossover study across 36 specialist centres in the US. Patients were given frovatriptan at two different dose levels (2.5 mg once a day or 2.5 mg twice a day) as well as placebo treatment for six days over three monthly cycles. The primary endpoint for the study was the complete prevention of menstrual migraines. This result was achieved in over half of the patients taking frovatriptan at the highest dose, and around 40% were headache-free on the lower dose, compared to 26% on placebo. Both doses were highly statistically superior to placebo (p<0.0001).

Commenting on the results, Dr Silberstein said: “In my opinion, this is one of the most impressive clinical trials of the short-term prevention of menstrual migraine.”

Other measures of effectiveness (secondary endpoints) confirmed during the trial were also positive, including frovatriptan’s ability to reduce:

  • headache severity – patients were approximately 2.5 times less likely to experience a severe headache with the higher dose of frovatriptan compared with placebo
  • headache duration – headaches lasted on average twice as long on placebo compared with the higher dose of frovatriptan
  • other symptoms associated with the headaches (photophobia, phonophobia, nausea and vomiting) and the need to use other treatments as rescue, and
  • the overall impact on patients’ daily activities.

Dr John Hutchison, Vernalis’ Chief Medical Officer, said: “These results are consistent with the 26-hour long half-life of the drug in the bloodstream, which is the key distinguishing feature of frovatriptan compared to other drugs in the triptan class. We believe that prophylaxis of menstrual migraine could add a significant new therapeutic dimension to frovatriptan once the required additional work has been completed and approved by the regulatory authorities.“

Around 16% of women suffer from migraines and recent studies suggest that as many as 50% of female migraineurs report that menstruation is a trigger for their migraine attacks (MacGregor et al.). One possible explanation is that the hormonal changes which are believed to be the trigger for menstrually associated migraine continue over a number of days.

Frovatriptan, a 5-HT1B/D agonist, was developed by Vernalis and is approved in the USA and the European Union for the acute treatment of migraine. It is currently marketed in the USA, Germany and Ireland.

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