The History of Botox
The existence of botulinum toxin has been known for centuries; however, its positive effects have only been appreciated in recent decades. In 1895 Professor Emile Pierre van Ermengem, of Ellezelles, Belgium1 identified the bacterium Bacillus botulinus. The agent, later renamed Clostridium botulinum, was the precursor to what is now known as botulinum toxin type A (BOTOX�).
It's believed that botulinum toxin type A was first isolated in purified form as a stable acid precipitate in the 1920s by Dr. Herman Sommer at the University of California, San Francisco.1 The resulting precipitate provided the basis of raw material for future studies.2,3
In 1946 Edward J. Schantz, Ph.D., and colleagues succeeded in purifying botulinum toxin type A in crystalline form.4,5 For the first time, researchers had the raw material they needed to study botulinum toxin type A in greater detail. The first major result of these studies occurred in the 1950s, when Dr. Vernon Brooks discovered that botulinum toxin type A, when injected into a hyperactive muscle, blocked the release of acetylcholine from motor nerve endings, thus inducing a temporary "paralysis" of the targeted muscle.2,3 Dr. Brooks' breakthrough sparked new interest in botulinum neurotoxin as a potentially significant therapeutic agent.4,5
In the 1960s and 1970s, Alan B. Scott, M.D., of the Smith-Kettlewell Eye Research Foundation tested botulinum toxin type A in monkeys to determine if the drug might be an effective therapy for strabismus, a type of "ophthalmic dystonia," in humans. Having heard about Dr. Schantz's research with botulinum toxin, Dr. Scott contacted Dr. Schantz at the University of Wisconsin to obtain product samples. Dr. Scott found that by injecting a small amount of botulinum toxin in the hyperactive ocular muscles in monkeys he was able to correct the strabismic condition. For the next 20 years, Dr. Schantz collaborated with Dr. Scott to develop botulinum toxin type A for human treatment.5
In the late 1970s, Dr. Scott formed his own company, Oculinum, Inc., where he continued to study botulinum toxin type A. Then, in 1978, Dr. Scott received permission from the Food and Drug Administration (FDA) to test botulinum toxin type A in human volunteers.4,5
In 1988, Allergan acquired the rights to distribute Dr. Scott's botulinum toxin type A product, Oculinum, and the responsibilities to conduct clinical trials of the drug's effectiveness for other indications, including cervical dystonia. In 1989, Oculinum, Inc. received FDA approval to market Oculinum in the United States as an orphan drug to treat strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorder in patients 12 years of age and older.
Shortly after the FDA approved these indications, Allergan Inc., acquired Dr. Scott's company. Based on the success of botulinum toxin type A therapy in the treatment of strabismus and blepharospasm associated with dystonia, Allergan applied for and received FDA approval to change the product's name to BOTOX� - a modification that aligned the product with Allergan's strategy to develop additional applications.
In 2000, the FDA approved BOTOX� for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with this disease.
BOTOX� currently is in use or under study as a treatment in more than 70 countries worldwide. |
