In this study we evaluated the efficacy of a new preparation (Fast Dissolving Dosage Form--FDDF) of piroxicam (40 mg in a single sublingual dose) in the acute treatment of migraine. The study plan was of single blind type versus placebo and involved 40 patients with migraine without aura (according to the IHS Classification criteria) who had to take Piroxicam FDDF (or placebo) within 2 hours from the beginning of a migraine attack. Pain intensity and associated symptoms were evaluated in the basal condition and then monitored at serial intervals for 24 hours. In the group of patients treated with the active drug (n = 20), a significant reduction of pain intensity (Visual Analogue Scale) was observed after only 15 minutes (P = 0.0034). After an hour, headache has disappeared in 15 patients, become mild in 4 and remained unchanged in only one subject. Associated symptoms also quickly disappeared after Piroxicam FDDF administration and headache recurred in only two patients within the 24 hour period. Sublingual administration of Piroxicam FDDF was well tolerated: no systemic side-effects were reported and only two subjects complained about mouth dysesthesias which were described as mild and short-lasting. In conclusion, Piroxicam FDDF has been shown in this preliminary study to have striking efficacy in the acute treatment of migraine. The treatment is characterized by quick onset, long duration and good tolerability.