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This article was originally published in The Tan Sheet

Executive Summary

Topical cream is "effective and safe" for acute migraine pain in 40-person, placebo-controlled parallel trial, F. Freitag, Diamond Headache Clinic, Chicago, et al., report in poster presented at the American Society for Clinical Pharmacology & Therapeutics annual meeting in Orlando March 6-10. Delivered via a patch, lidocaine cream demonstrated "significant" pain reduction among migraine sufferers after eight hours. On a 10-point scale, baseline pain fell from a mean of 6.93 to 5.51 after two hours and to 1.70 after eight. No significant adverse events were observed, the researchers report. Sponsor Epicept, an Englewood Cliffs, N.J.-based pharmaceutical firm exploring pain management, plans to seek FDA approval of lidocaine products indicated for back ache, headache and migraine. The firm intends to conduct additional Phase II studies and a Phase III trial of 500-600 people by early 2002

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