Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Allergan’s Botox Enters Phase III Clinical Trial for Major Depressive Disorder



The mid-stage trial evaluated the tolerability of two doses of Botox (30 units or 50 units) in female patients diagnosed with MDD.

Share this!

April 7, 2017 | by Sarah Hand, M.Sc.

Earlier this week, Dublin-based pharmaceutical company, Allergan, announced topline data from a Phase II clinical trial investigating the safety and efficacy of Botox to treat patients with Major Depressive Disorder (MDD). While the blockbuster drug was considered to be numerically superior in terms of efficacy, when compared to a placebo, the study team could not prove statistical significance.

The mid-stage trial evaluated the tolerability of two doses of Botox (30 units or 50 units) in female patients diagnosed with MDD. In all, 258 patients with severe MDD were enrolled in the trial, based on their scores on two major depression scales, the Hamilton Rating Scale for Depression and the Clinical Global Impressions Scale.

Patients were randomly assigned to receive a 30 or 50 unit dose of Botox, or a placebo. The study investigators measured the primary endpoint as the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline to week six of the study.

According to Allergan, the 30 unit dose of Botox showed numerical superior efficacy in achieving the primary endpoint, compared to the placebo. Patients taking this dose showed an average treatment difference of -3.7 in the MADRS total score at week six of the study.

Patients taking the 50 unit dose of Botox did not show numerically superior efficacy over the placebo. Despite this, both doses were well tolerated in patients.

“We are encouraged by these data and the potential impact on adults with major depressive disorder,” said David Nicholson, Chief Research and Development Officer, Allergan. “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.”

Though Allergan did not report statistically significant results – the gold standard of showing efficacy over a placebo – the drugmaker has announced that Botox will be pushed forward into a Phase III clinical trial for MDD. While it’s not clear when this late-stage trial will commence, it’s likely that Allergan will only include the lower dose in the next phase.

Originally approved as a cosmetic product to reduce wrinkles on the face and neck, Botox has since been approved for a number of additional medical indications, including excessive perspiration, migraines and muscle stiffness. In 2016, global sales of Botox reached $2.8 billion, making it Allergan’s best seller.

Keywords:  Clinical Trial, Depression, Blockbuster


Share this with your colleagues!

Kite Pharma Secures FDA Approval for CAR-T Immunotherapy

October 20, 2017 - Kite Pharma’s Yescarta (axicabtagene ciloleucel) has become the second CAR-T immunotherapy to be approved in the US, with an indication in treating adult patients with relapsed or refractory large B-cell lymphoma.

Featured In: Biotech News

Fallopian Tubes Found to be Site of Origin for Most Ovarian Cancers

October 20, 2017 - This year, over 22,000 women will be diagnosed with ovarian cancer but a new study conducted by researchers at Perlmutter Cancer Center at NYU Langone Health suggests that most of these malignancies begin in another part of the reproductive system: the fallopian tubes.

Featured In: Life Science News

Food Companies are Looking for the Next Sriracha

October 19, 2017 - The Sriracha trend might be coming to an end and companies are looking for the next big hot sauce star to feature in their line-up.

Featured In: Food News


Five Reasons Why Toronto is Emerging as a Major Life Sciences Hub


Brexit – Separating Fact from Fiction

Evolving Best Practices for Working with Authors of Scientific Publications – Authorship and Beyond

Human Whole-Genome Sequencing in a New Era Defined by the Illumina® HiSeq X® and NovaSeq™ Platforms

Clinical Event Adjudication: Comprehensive and Efficient Dossier Review Using a Global On-Line Solution

Copyright © 2016-2017 Honeycomb Worldwide Inc.