Effectiveness of a Piroxicam Fast Dissolving Formulation Sublingually Administered in the Symptomatic Treatment of Migraine Without Aura

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Abstract
SYNOPSIS In this study we evaluated the efficacy of a new preparation (Fast Dissolving Dosage Form ‐ FDDF) ofpiroxicam (40 mg in a single sublingual dose) in the acute treatment of migraine. The study plan was ofsingle blind type versus placebo and involved 40 patients with migraine without aura (according to the IHSClassification criteria) who had to take Piroxicam FDDF (or placebo) within 2 hours from the beginning of amigraine attack. Pain intensity and associated symptoms were evaluated in the basal condition and thenmonitored 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 hasdisappeared in 15 patients, become mild in 4 and remained unchanged in only one subject. Associatedsymptoms also quickly disappeared after Piroxicam FDDF administration and headache recurred in onlytwo patients within the 24 hour period. Sublingual administration of Piroxicam FDDF was well tolerated: nosystemic side‐effects were reported and only two subjects complained about mouth dysesthesias whichwere described as mild and short‐lasting.In conclusion, Piroxicam FDDF has been shown in this preliminary study to have striking efficacy in theacute treatment of migraine. The treatment is characterized by quick onset, long duration and goodtolerability.

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