Frova(R) Meets Primary Endpoint in Second Phase III Study for Prevention of Menstrual Migraine
Monday May 8, 2:00 am ET
- Data to be Included as Part of Supplemental NDA to FDA -
WINNERSH, England and CHADDS FORD, Pa., May 8 /PRNewswire-FirstCall/ -- Vernalis plc (LSE: VER, Nasdaq: VNLS) and Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP - News) today announced top-line data from the second Phase III efficacy study of Frova® (frovatriptan succinate) 2.5 mg tablets for the short-term (six-days per month) prevention of menstrual migraine (MM). The data from this study corroborate the positive findings in a prior efficacy study published in Neurology in July 2004 (ref: 2004, 63: 261-269). Endo expects to file a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) in the coming weeks to seek approval for the additional indication of Frova® for the prevention of menstrual migraine.
If approved, Frova® will be the only triptan indicated in the US for the prevention of MM. Frova® is FDA-approved for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established.
"Menstrual migraines can have significant impact on a woman's life. The preliminary results of this study are encouraging for women who suffer from menstrual migraine and who have not responded well to acute treatment," said the lead investigator in the trial, Jan Lewis Brandes, M.D., of the Nashville Neuroscience Group and of the Department of Neurology at Vanderbilt University School of Medicine.
"There is an unmet need for a new treatment option that is well-tolerated, effective and capable of preventing menstrual migraine from occurring," stated Stephen Silberstein, M.D., professor of neurology at the Jefferson Medical College of Thomas Jefferson University, director of the Jefferson Headache Center and lead investigator of the initial efficacy study of Frova® for the short-term prevention of menstrual migraine. "Menstrual migraine sufferers deserve a treatment tailored to their condition."
Study Results
Patients in the study were treated for three peri-menstrual periods (PMPs) and the primary endpoint was the number of menstrual migraine-free PMPs. Both once and twice-daily dose regimens of Frova® demonstrated efficacy, with statistical significance compared to placebo (p<0.01 and p<0.001 respectively). In addition, both dose regimens achieved statistical significance in other measures of effectiveness. These secondary endpoints included increased number of PMPs with one or no days of mild headache, reduction in headache intensity and a reduction in the use of rescue medication. There were no serious adverse events attributed to Frova®. The frequency of other adverse events was similar across both active treatment arms and placebo.
To be eligible for entry into this study, patients had to have previously been exposed to non-triptan therapy (i.e. NSAIDs - non-steroidal anti-inflammatory drugs) for the treatment of menstrual migraine episodes and had to have responded inadequately to acute triptan therapy. Prior to randomisation all patients had to experience an MM during a one-month placebo run-in. The 427 eligible patients were randomised to either placebo, once- daily or twice-daily dosing with Frova® and were treated for six days in each of three menstrual cycles, with therapy starting two days before the expected onset of menstrual headache. A more comprehensive presentation of the data from this trial will be provided at an appropriate scientific forum later this year.
Simon Sturge, chief executive officer of Vernalis, confirmed "We are delighted to have achieved a positive outcome from this confirmatory efficacy trial with Frova®. The women in this study represent a difficult-to-treat population, each having previously failed acute therapy. These results underscore our belief in the potential of Frova®."
"We are excited about the outcome of this trial," said Peter A. Lankau, president and chief executive officer of Endo, which markets Frova® in the US. "Frova® may offer millions of women a promising therapy for their monthly migraines. We look forward to working with the FDA to bring Frova® to market as a preventive treatment for menstrual migraine." He added that, if approved, Frova® would be the only triptan indicated for the prevention of menstrual migraine in the US, with its unique dosing regimen of six days per month.
Analyst Conference Call
Simon Sturge, Tony Weir and John Hutchison, CEO, CFO and Development Director of Vernalis respectively, will today host an analyst / investor presentation and conference call at 10:00 am BST to discuss the data. This may be accessed by dialling: +44 1452 561 394, and quoting 'Vernalis conference call.' |
