Frova performs well in second Ph II MM study

UK-based biopharmaceutical company Vernalis and US company Endo Pharmaceuticals have announced new data from a second Phase III efficacy study of Frova (frovatriptan succinate) for the prevention of menstrual migraine. The product, which is available in 2.5mg tablet form, is designed for short-term treatment of the condition.

The trial enrolled 427 patients who had previously been treated with non-steroidal anti-inflammatory drugs and had experienced at least one menstrual migraine in the month prior to the program. The subjects were randomized to receive either placebo or the drug once or twice-daily for six days every cycle for a total of three months. The results revealed that both dosing regimens were effective in the treatment of the condition in comparison with placebo (p<0.01 and p<0.001, respectively). The firms say that the drug also reduced the level of headache intensity and the need for rescue medication. The findings also support data from an earlier Phase III assessment which were published in the journal Neurology, in July 2004.

Frova was first approved for the treatment of acute migraine by the US Food and Drug Administration late in 2001 (Marketletter passim). Endo says that it expects to file a supplemental New Drug Application with the agency for the MM indication in the next few weeks.