Barcelona - November 2, 2010 -- Diclofenac potassium (DFP) as a powdered formulation for oral solution use is well tolerated and provides rapid and effective pain relief for patients with migraine, with or without aura, researchers reported here at the 4th World Congress on Controversies in Neurology (CONy). "Diclofenac potassium is a nonsteroidal anti-inflammatory that … works in migraine," stated coinvestigator Alan M. Rapoport, MD, The David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California. He presented 2 randomised, double-blind, double-dummy, controlled trials here on October 30. The 2 trials investigated the readily soluble, powdered formulation of DFP designed to provide patients with more rapid pain relief. The trials were in Europe and the United States, and, in both, enrolment was for adults (18-65 years of age) suffering from migraine with or without aura, with 1 (Europe study) or 2 (US study) to 6 migraines per month. In the European study, 317 patients were randomised to compare placebo, 50 mg DFP tablets, or 50 mg DFP powder. In all, 888 migraine attacks were recorded (n = 299, 298, 291, respectively). In the US study, 807 patients were randomised to compare placebo (n = 347) and DFP 50 mg powder (n = 343). As a primary endpoint in both trials, compared with placebo, DFP powder provided significantly improved pain-free response at 2 hours (Europe: 11.7% vs 24.7%, [P <.0001; US: 10.1% vs 25.1%, P <.01). The coprimary endpoints at 2 hours in the US trial were similarly significantly beneficial: nausea-free (52.7% vs 64.7%, P <.002); photophobia free (27.4% vs 40.5%, P <.001); and phonophobia free (27.4% vs 44.3%, P <.001).
There was also a range of secondary endpoints versus placebo in each trial, most of which showed significant benefit for DFP powder. In the European trial, secondary endpoints showed benefit over placebo: headache response at 2 hours (24.1% vs 46.0%, P <.0001); sustained headache response 24 hours (18.4% vs 36.8%, P <.0001); sustained pain-free 24 hours (9.4% vs 22.3%, P <.0001); and average headache intensity reduction at 2 hours (7.0% vs 16.6%). Four-hour recurrence rates were not significantly different (21.1% vs 15.5%). In the US trial, similar benefits over placebo were also demonstrated: sustained pain-free 24 hours (7.2% vs 19.0%, P <.001) and pain intensity difference at 30 minutes (0.30 vs 0.40, P =.013). Here also, 4-hour recurrence rates were not significantly different (29.0% vs 24.0%), and there were benefits for restoration of function at 2 hours and 24 hours (16.1% vs 33.2%, 36.9% vs 54.5%); and headache response rate at 2 hours (41.6% vs 64.7%). In the European trial, the tablet formulation of DFP generally showed intermediate, and generally significant, results between placebo and DFP powder. In the safety analyses, for both trials the incidence of adverse events was comparable to placebo, with no serious adverse events. The most prevalent adverse events for placebo and DFP powder were nausea (2.0% vs 3.0%) and dizziness (0.5% vs 1.0%). Finally, in considering that migraine probably starts in the cerebral cortex, with inflammation in the meninges and brainstem, Dr. Rapoport concluded, "Even though this process is much more complex, the fact of the matter is, this drug works to take away migraine fairly quickly." Funding for this study was provided by Nautilus Neurosciences Inc. [Presentation title: Rapid and Sustained Improvement in Migraine Symptoms With a New Powdered Formulation of Diclofenac Potassium for Oral Solution: Results From 2 Randomized, Controlled Clinical Trials. Abstract B23]
|
