LONDON - Shares in Vanguard Medica plc fell by 51.5 pence to #1.45 last week when the FDA asked for further non-clinical data to support the approval of frovatriptan for the treatment of migraine. It will take nine months to complete the further toxicological studies requested by the FDA.

A spokesman for Guildford-based Vanguard told BioWorld International, "Frovatriptan is highly non-toxic as a compound, and on advice, the long-term toxicology was done at 100 times the human dose, which seems reasonable for a chronic-use compound.

"The FDA decided on a belt-and-braces approach and has asked for long-term tox at a higher dose." This dose is to be agreed between the FDA and the company. The dossier has not been withdrawn.

The review for registration in Europe is ongoing. The spokesman said regulators have been informed, as has the European marketing partner Menarini, of Italy. There is no indication yet whether the European regulators will ask to see the new data. - Nuala Moran