Recruitment under way in confirmatory FrovaŽ efficacy study for prophylaxis of menstrually related migraine
23 November 2004
Vernalis plc (LSE:VER, Nasdaq: VNLS) is pleased to announce that recruitment has started in the confirmatory Phase III study to complete the required data package for filing a supplemental New Drug Application (sNDA) for FrovaŽ (frovatriptan) for the prophylaxis or prevention of menstrually-related migraine (MRM). If this efficacy study and the ongoing safety study are successful, a regulatory submission in the US can be expected in the first-half of 2006. Regulatory approval would permit FrovaŽ to be marketed as a short-term prophylaxis for MRM in the US. FrovaŽ is marketed in the US by our partner, Endo Pharmaceuticals Inc.
The first patients were recruited into this study in late October 2004. This is a placebo-controlled parallel group study investigating the same dose regimens that were found to be effective in the initial study, published in Neurology in July 2004. Around 600 patients whose menstrually-related migraines are not adequately treated using acute therapies will be enrolled, and treated for three consecutive months.
In April 2004, a 12-month safety study was fully recruited when a total of 562 participants had been enrolled. The purpose of this study is to provide safety information on a minimum of 300 women following six cycles of treatment and 100 women following 12 cycles of treatment. In excess of 300 women have now received six cycles of treatment. If the trial continues as expected for the remaining six months, the complete dataset will be available from this study in the second half of 2005.
In April 2003, positive trial data were first presented from a study of over 500 menstrual migraine sufferers in the US, demonstrating that short-term prophylaxis with frovatriptan was effective in preventing migraine headaches triggered by menstruation. The data demonstrated a highly statistically significant improvement in the numbers of patients who were headache-free during their peri-menstrual periods for both once and twice daily dose regimens of frovatriptan compared to placebo (p 0.0001). These data were published in full by a leading journal (Neurology 2004; 63: 261-269).
Continuing Marketing Progress in Europe
Frovatriptan has recently been launched in Spain by our European
partner, the Menarini Group. Frovatriptan has now been approved for
the acute treatment of migraine in 16 European countries and is on
the market in Germany, Italy, UK, Austria and the Netherlands, with
further launches in other countries expected in 2005. In Germany,
where frovatriptan was launched in November 2002, it has now
increased its market share to 9.5% by prescription.
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About FrovaŽ
FrovaŽ was approved
by the FDA on November 8, 2001 for the acute treatment of migraine
attacks with or without aura (subjective symptoms at the onset of a
migraine headache) in adults. FrovaŽ is generally well
tolerated, with a side-effect profile that is typical of the
triptan class of drugs. The most common side effects are dizziness,
fatigue, paresthesia (tingling), flushing, headache, dry mouth, hot
or cold sensation, and chest pain. The FDA-approved dosing for
FrovaŽ is one 2.5 mg tablet up to three times within a 24-hour
period. FrovaŽ has not been approved by the FDA for any
indications other than for the treatment of acute migraine
headaches, and its safety and efficacy in other indications have
not been established.
Enquiries:
Vernalis plc
Simon Sturge, Chief Executive
Officer
Tony Weir, Chief Financial Officer
John Hutchison, Development Director
+44 (0)118 977 3133
Brunswick Group (for analyst, financial media
enquiries)
Jon Coles
Wendel Carson
+44 (0)20 7404 5959
