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

XTALKS VITALS NEWS

Botox

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


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Exclusion Criteria for Clinical Trials Poses Major Barrier to Patient Enrollment

August 17, 2017 - UT Southwestern researchers say that clinical investigators continue to increase the number of exclusion criteria, preventing more patients from participating in clinical trials.

Featured In: Clinical Trials News


Targeting Cellular Nitrogen Metabolism Could Offer a New Treatment for Pancreatic Cancer

August 17, 2017 - An enzyme involved in regulating the amount of nitrogen in the cell could be a new drug target for pancreatic cancer, according to researchers from Boston Children's Hospital and the Broad Institute of MIT and Harvard.

Featured In: Life Science News


Regeneron’s Drug for Respiratory Syncytial Virus Fails in Phase III Clinical Trial

August 16, 2017 - Biotechnology company Regeneron has announced it will not continue development of its antibody drug, suptavumab, after a failure in a Phase III clinical trial.

Featured In: Clinical Trials News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

One Patient’s Perspective on Clinical Trials

REGISTER FOR THESE WEBINARS

Planning and Conducting Trials of the Latest Immunotherapies


ISO 13485:2016 for Medical Device Manufacturers: Ensuring a Smooth Transition through Effective Preparation


Medical Devices: Reviewing Regulatory Changes in the US and EU


Moving Beyond Regulatory and Performance Metrics in Starting Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.