Botox Misses Mark in Headache Study

Allergan (AGN) is planning late-stage trials for its cosmetic injection Botox as a headache treatment, but the company said Thursday that in a recent study, researchers found no statistically significant differences between the drug and a placebo after 180 days.

The results came from phase II trials to gather preliminary safety and efficacy data on Botox as a treatment for chronic daily headaches. However, the company said the results may have been confounded by a large number of patients taking preventive headache medications during the studies.

Statistically significant results were found in certain subsets of patients. The company said it did find that the drug decreases the frequency of headaches, reduces the number of days with headaches by at least 50% and lowered patients' use of acute medication.

Additional studies are needed to further examine the effect of Botox in treating chronic daily headaches, as well as less frequent episodic migraines. Allergan will begin a phase III trial in late 2005 to investigate the safety and effectiveness of Botox in a subset of migraine patients with chronic daily headaches.

Allergan shares fell 57 cents to $85.18 Thursday.

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