…statistically significant but not clinically significant.
In this regard, Botox for migraine is a lot like ALKS’ Vivitrol for alcohol addiction; in both cases, there was a very large placebo benefit that was almost as large as the drug benefit but the difference was nevertheless statsig.
Perhaps the endpoint of “affected days” per month makes it too easy for a marginal treatment to achieve a statsig outcome. If I were at the FDA, I would not be inclined to allow such a primary endpoint in future studies.
p.s. The similarity of Botox for migraine and Vivitrol for alcohol addiction does not extend to their commercial prospects. Vivitrol will always be a commercial dog, IMO, while Botox for migraine could reach half a billion dollars per year in due course.
Err, your error is in error. The published results indicate that the reduction was per month, with the primary endpoint being the 4-week period ending at week 24 compared as a change from the baseline 4-week period. The counts (each of headache days and headache hours) were cumulative over the 4-week period; not cumulative over the 6-month period.
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