Allergan (AGN) Reports Positive Results from Two Phase III Trials on BOTOX(R) Headache Treatment
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Allergan, Inc. (NYSE: AGN) today announced that it has completed a top-line analysis of its two Phase III clinical trials exploring the use of BOTOX(R) for the prophylactic treatment of headache in adults suffering from chronic migraine - i.e., headaches and/or migraines that occur on 15 or more days each month.
BOTOX(R) is the first therapy being investigated for this extremely debilitating condition of chronic migraine, which is estimated to affect between 1.2 and 3.6 million people in the United States(1a,b).
In the first Phase III clinical trial, Allergan prospectively selected number of headache episodes as the primary endpoint for evaluation. Number of headache days was selected as the major secondary endpoint. Results from the first Phase III clinical trial indicated that although both the BOTOX(R) and placebo treatment groups showed a statistically significant improvement from baseline, there was no significant difference in the reduction of number of headache episodes between patients receiving BOTOX(R) and placebo. However, the study showed a decrease in number of headache days, the FDA's preferred efficacy measure, that was significantly greater in patients receiving BOTOX(R) vs. patients receiving placebo (p=0.006). The decrease in number of migraine/probable migraine days was also found to be significantly greater in patients treated with BOTOX(R) vs. patients receiving placebo (p=0.002).
Based on the data from the first Phase III clinical trial, the primary endpoint for the second Phase III study was prospectively changed to number of headache days, with number of headache episodes changed to a secondary endpoint, before the data were unmasked. In the second Phase III study, the primary endpoint and key secondary endpoints showed statistically significant benefit of BOTOX(R) treatment over placebo injections. Specifically, patients treated with BOTOX(R) demonstrated a significantly greater decrease in both number of headache days (p less than 0.001) and number of headache episodes (p=0.003). Similar to the first Phase III trial, the second study also showed a decrease in number of migraine/probable migraine days that was significantly greater in patients treated with BOTOX(R) vs. placebo (p less than 0.001)
Allergan, Inc., a multi-specialty healthcare company, discovers, develops, and commercializes specialty pharmaceutical, medical device, and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatological, breast aesthetics, obesity intervention, urological, and other specialty markets worldwide.
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