Allergan PLC reported topline data from a phase 2 study evaluating two different doses of Botox relative to placebo in adult females with major depressive disorder.
Primary endpoint for the study was change from baseline to week six in Montgomery-Asberg depression rating scale total score for the doses versus placebo, and a combination of the two doses compared with combined placebo groups.
The 30 units dose of the drug demonstrated numerically superior efficacy in total score on the Montgomery-Asberg depression rating scale compared to placebo, while the 50 units dose did not demonstrate superior efficacy over placebo.
Both secondary efficacy variables showed numerically superior efficacy over placebo and trended in the same direction as the primary efficacy variable for the 30 units dose, but not for 50 units dose.
Allergan chief research and development officer David Nicholson said in a statement that the company plans to move forward and develop a phase 3 program for a potential new treatment option for patients.