New Botox for Depression Research Published in Pharmacopsychiatry

Treating Depression with Botulinum Toxin: A Pooled Analysis of Randomized Controlled Trials

Abstract

Introduction: Botulinum toxin A (BTA) injection into the glabellar region is currently being studied as a treatment for major depressive disorder (MDD). Here we explore efficacy data of this novel approach in a pooled analysis.

Methods: A literature search revealed 3 RCTs on this topic. Individual patient data and clinical end points shared by these 3 trials were pooled and analyzed as one study (n=134) using multiple regression models with random effects.

Results: In the pooled sample, the BTA (n=59) and the placebo group (n=75) did not differ in the baseline variables. Efficacy outcomes revealed BTA superiority over placebo: Improvement in the Hamilton Depression Rating Scale or Montgomery-Asberg Depression Rating Scale 6 weeks after baseline was 45.7% for BTA vs. 14.6% for placebo (p<0.0001), corresponding to a BTA response rate of 54.2% (vs. 10.7%) and a BTA remission rate of 30.5% (vs. 6.7%).

Discussion: Equalling the status of a meta-analysis, this study increases evidence that a single treatment of BTA into the glabellar region can reduce symptoms of MDD. Further studies are needed to better understand how BTA exerts its mood-lifting effect.  Read More…

 

 

LISTEN LIVE WNPR Radio Today 12/11 at 1:00PM

Colin McEnroe ShowDr. Eric Finzi will be a guest on NPR Boston’s The Colin McEnroe Radio Show today at approximately 1:06PM EST talking about the Botox for Depression research study findings published in the Journal of Psychiatric Research (May 2014). The study “Treatment of Depression with onabotulinumtoxinA: A Randomized Double-Blind, Placebo Controlled Trial” found that 52% of subjects suffering from moderate to severe depression showed a relief from depression after injection of botulinum toxin to the glabellar area between the eyes, compared with only 15% of those who received the saline placebo. A second phase to this study is in the works.

This year marks commemorates the 25th anniversary of the first approved uses of BOTOX® and to honor its heritage as a medical advancement. You can listen to the program LIVE at http://wnpr.org/programs/colin-mcenroe-show and click on “stream us live” link.

The following information is published on Allergan, the makers of Botox’s  website:

While BOTOX® Cosmetic (onabotulinumtoxinA) has become a household name, BOTOX® was the first botulinum toxin type A treatment to be approved by the U.S. Food and Drug Administration as an orphan drug for two rare, eye muscle disorders.  This journey, which started in 1989, began with the approval of BOTOX® to treat strabismus (a misalignment of the eyes, commonly known as crossed eyes) and blepharospasm (uncontrolled blinking of the eyelid).  Strabismus affects nearly four in every 100 adults,1 and blepharospasm affects an estimated 20,000 to 50,000 people in the United States, with 2,000 new cases diagnosed annually.2 Since that time, BOTOX® therapeutic has been approved for other significant medical conditions including Cervical Dystonia, Severe Underarm Sweating when topical agents don’t work sufficiently, Upper Limb Spasticity, Chronic Migraine, Overactive Bladder when an anticholinergic doesn’t work or the side effects are intolerable, and urinary incontinence due to overactive bladder caused by a neurologic condition when an anticholinergic doesn’t work or the side effects are intolerable.

“BOTOX® is an innovative product whose potential to treat medical conditions across a variety of therapeutic categories continues to expand even today,” said David E.I. Pyott, Chairman of the Board and Chief Executive Officer, Allergan.  “The more we research the medical value of this treatment, the more we learn about this biologic and the areas of clinical unmet need where it may provide some benefit.  Since BOTOX® was first approved 25 years ago, the list of indications it treats has grown exponentially – not just in the United States, but globally.  Today, physicians in 88 countries treat 27 different conditions with BOTOX® and the possibilities continue to grow with Allergan’s research.”3

The video, which outlines the 25-year history of development for BOTOX® therapeutic, features first-hand accounts from patients who chronicle their journey from diagnosis to treatment, as well as physicians who share their personal experiences in advancing the development of this brand, showcasing its therapeutic roots.

For each person that views the video, Allergan will support four patient advocacy organizations that are partnering with the company to help raise awareness, educate and support people living with any of the medical conditions currently being treated with BOTOX®.  Support will be given to:

  • Benign Essential Blepharospasm Research Foundation (BEBRF)
  • Dystonia Medical Research Foundation (DMRF)
  • National Headache Foundation (NHF)
  • National Association for Continence (NAFC)

“The history of BOTOX® therapeutic is really a remarkable story of how a substance from nature has been successfully harnessed for medical benefit,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development and Chief Scientific Officer, “It’s also a human interest story that starts with the scientists and the physicians who observed the impact of BOTOX® in treating certain medical conditions, tracked that impact and did something about it.  Without this pioneering spirit, we would not have been able to pursue the clinical development and FDA approval of many of the therapeutic indications we now have for BOTOX®.”

To learn more about BOTOX® and to view the 25th anniversary video please visitwww.BOTOX.com.

About BOTOX®(onabotulinumtoxinA)BOTOX® is a prescription-only medical product that contains tiny amounts of a highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum.  When injected at doses approved by the U.S. Food and Drug Administration (FDA) into a specific muscle or gland, BOTOX® neurotoxin is expected to produce a safe, as well as effective result, usually lasting up to approximately three to ten months, depending on the approved indication and on the individual patient.

BOTOX®was first approved in 1989 by the U.S. Food and Drug Administration (FDA) for the treatment of two eye muscle disorders, making it the first botulinum toxin type A product to be approved in the world.  Since then, BOTOX®has been recognized by regulatory authorities as an effective treatment for 27 different indications in approximately 88 countries, benefiting patients worldwide.

Today, BOTOX®neurotoxin is approved to treat a total of eight medical conditions in the United States, including:

  • the treatment of overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken;
  • the treatment of leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication;
  • the prevention of headaches in adults with chronic migraine who have 15 or more days each month with headache lasting four or more hours each day in people 18 years or older;
  • the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in people 18 years and older with upper limb spasticity;
  • the treatment of the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older;
  • the treatment of certain types of eye muscle problems (strabismus) in people 12 years and older;
  • the treatment of abnormal spasm of the eyelids (blepharospasm) in people 12 years and older; and
  • the treatment of symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.