Allergan reports topline Phase II data supporting advancement of Botox for the treatment of MDD

Botox is currently being studied as a potential treatment option for adult patients with moderate to severe MDD.

Allergan has announced topline data from a Phase II study with Major Depressive Disorder (MDD). The study evaluated the efficacy, safety and tolerability of a single administration of 2 different doses of Botox (30 units or 50 units) relative to placebo in adult females with MDD over duration of up to 24 weeks.

The Botox 30 U dose demonstrated numerically superior efficacy in MADRS total score compared to placebo. The treatment (LS mean) difference for 30 U was -4.2 at 3 weeks; -3.7 at week 6 and -3.6 at week 9. The primary end point was at week 6. The 50 U did not demonstrate superior efficacy over placebo (LS mean difference was 1.3). Both secondary efficacy variables (CGI-S and HAMD-17) showed numerically superior efficacy over placebo and trended in the same direction as the primary efficacy variable for 30 U, but not for 50 U. Both 30 U and 50 U were well tolerated.

"We are encouraged by these data and the potential impact on adults with major depressive disorder. Given our in-depth and extensive clinical trial experience in CNS including depression, we plan to move forward and develop a Phase III program for  a potential new treatment option for patients," said David Nicholson, Chief Research and Development Officer, Allergan.