A fast-acting transdermal gel using a proprietary formulation of the nonsteroidal anti-inflammatory drug (NSAID) ketoprofen helps in reduced pain severity in patients with severe migraine with or without auracompared with placebo and had few adverse effects. The phase 2a trial results were presented at the American Academy of Neurology (AAN) 67th Annual Meeting. The study shows the pathogenesis of severe headaches that are due to neurogenic inflammation. If proved in large-scale trials, it may be new era in neurological practice and introduction of new topical treatment of migraine. Oral analgesics such as cyclooxygenase inhibitors reduce inflammation but cause undesirable gastrointestinal effects.
Study is placebo-controlled, randomized, cross-over include 42 adults between 18 and 65 years of age The subjects were diagnosed with episodic, moderate to severe migraine with or without aura. The patients received application of a pea-sized, topical gel over the peripheral trigeminal nerve ends, on all six points. The patients were grouped based on baseline headache intensity.
The pain episodes were inquired for 24 hours after treatment and the responses were noted. The efficacy of the gel was assessed on baseline and multiple time points after treatment up to 24 hours. Study results ketoprofen gel was absorbed rapidly and comparatively better than any competing products. Among the subjects, 49 severe episodes of headaches reported in 22 gel-treated and 27 placebo treated subjects, respectively.
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