The 200-Year Timeline on Botulinum Toxin: From Biologic Poison to Wonder Drug

January 2024 | Volume 23 | Issue 1 | 1357 | Copyright © January 2024


Published online December 8, 2023

Joanna Dong MD, Eugene M. Helveston MD, C. William Hanke MD MPH

Ascension St. Vincent Hospital, Indianapolis, IN



had been working since the 1960s to find a novel surgery-sparing therapeutic to treat strabismus, learned of the effect of botulinum toxin on muscles and requested samples of BoNT-A from Dr Schantz.9 After successful results in Rhesus monkeys, Dr Scott published his breakthrough primate research in 1973.16 This research ultimately led to Food and Drug Administration (FDA) approval of the first human clinical trial of BoNT. In 1978, Dr Scott became the first to inject medicinal botulinum toxin into human subjects, with safe and effective results. In 1981, he published his seminal clinical trial results.17 After this initial success, more physicians joined Dr Scott's strabismus clinical trials as clinical investigators, including Dr Jean Carruthers, a Canadian ophthalmologist, who would go on to collaborate with her dermatologist husband, Dr Alistair Carruthers, in studying and popularizing the use of BoNT in cosmetic dermatology. Though aware of the aesthetic potential of BoNT for facial muscles and rhytides, Dr Scott expressed no interest in pursuing this indication himself. 

4) BoNT as a wonder drug: FDA approvals (1989-Present)
In 1989, the FDA issued the first landmark approval of BoNT-A for blepharospasm and strabismus associated with dystonia in patients twelve years and older. Numerous other medical and cosmetic indications followed in the coming decades. By the time of Dr Alan Scott's passing in 2021, 5 different commercial prod-ucts of BoNT [Botox (onabotulinumtoxin-A, Abbvie/Allergan Aesthetics), Dysport (abobotulinumtoxin-A, Galderma), Xeo-min (abobotulinumtoxin-A, Merz Pharmaceuticals), Jeuveau (prabotulinumtoxin-A, Evolus), and Myobloc (rimabotulinum-toxin-B, Solstice Neurosciences)] would be FDA approved in the US with a combined 28 different indications across the special-ties of ophthalmology, neurology, urology, dermatology, and otolaryngology (Figures 1 and 2). Most recently at the time of this writing, a 6th product, Daxxify (daxibotulinumtoxinA-lanm, Re-vance), has been approved by the FDA for cosmetic indication. 

DISCLOSURE

The authors have no conflicts of interest to declare.

REFERENCES

  1. Botulinum Toxin Market Size, Share & Trends Analysis Report, 2022-2030. Available at: https://www.grandviewresearch.com. Accessed Sept 19, 2022. 
  2. Bach K, Simman R. The multispecialty toxin: a literature review of botulinum toxin. Plast Reconstr Surg Glob Open. 2022;6;10(4):e4228. 
  3. Spiegel LL, Ostrem JL, Bledsoe IO. FDA Approvals and consensus guidelines for botulinum toxins in the treatment of dystonia. Toxins (Basel). 2020 May 17;12(5):332.