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Allergan to advance Botox trial to third phase for treatment of depression

PBR Staff Writer Published 06 April 2017

Allergan announced to advance its wrinkle treatment Botox to third phase after its phase II study showed a partial benefit in treating patients with major depressive disorder (MDD).

The trial had assessed the efficacy, safety and tolerability of a single administration of two different doses of Botox, including 30 units (30U) or 50 units (50 U), against placebo in adult females with MDD under 24-week period.

Botox 30 U has showed treatment benefit in Montgomery-Asberg depression rating scale (MADRS) total score compared against placebo, while 50 U did not demonstrate better efficacy as expected compared to placebo.

The trial’s secondary efficacy variables demonstrated multiple superior efficacy against placebo, and showed same result as the primary efficacy variable for 30 U, but not for 50 U.

According to the firm, the trial’s primary endpoint was change from baseline to week six in MADRS total score for Botox 30 U against placebo and Botox 50 U versus placebo, as well as combined Botox 30 U and 50 U versus combined placebo groups.

The trial is a proof of concept Phase II, multi-center, randomized, double-blind, placebo-controlled, two-dose cohort parallel group and single treatment study, which included adults females with MDD.

Allergan had selected 258 MDD patients in three groups to undergo treatment with either Botox 30 U (Unit dose), Botox 50 U or placebo in the trial.

Each study site was randomly assigned to only one of the doses and matching placebo, as the number of injections differed between the 30 U and the 50 U group.

Allergan chief research and development officer David Nicholson said: "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 3 program for  a potential new treatment option for patients.”

Botox is used to temporarily modify the appearance of facial wrinkles and Allergan believes that this modification of facial expression and muscle contractions through this can help in mitigating depression.

Botox is also being used for chronic migraine, overactive bladder, severe underarm sweating, eyelid spasms and limb spasticity, reported Reuters.

Image: Allergan headquarters in Irvine. Photo: courtesy of Coolcaesar.