Results from a Phase 2 proof-of-concept clinical trial assessing Allergan's (NYSE:AGN) BOTOX (onabotulinumtoxinA) in adult females with Major Depressive Disorder (MDD) showed a treatment benefit but the overall numbers failed to achieve statistical significance.
The 30-unit dose beat placebo numerically, but failed to hit the primary endpoint of a statistically valid increase in MADRS score versus placebo (p=0.053) at week 6. The difference was statistically significant at week 3 (p=0.005) and week 9 (p=0.049).
The 50-unit dose failed to beat placebo.
The company remains undeterred. It plans to proceed into Phase 3 development.
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