Before Botox became a widely used pharmaceutical for medical uses, the botulinum toxin was the root of the malady “botulism”.
Botulism is a deadly illness though these days few would have heard of it. In the United States roughly 110 cases are recorded each year. The disease is categorized as either food-borne botulism, infant botulism or wound botulism. The food-borne variety is usually caused by eating canned foods contaminated by the poison.
When botulinum toxin enters the body it causes the disease Botulism. It is a paralytic disease which ultimately causes death due to paralysis of the respiratory muscles. Food borne botulism was very common, with spoiled beef being a specific culprit. While in ancient times there had been little appreciation of the reason behind the illness, there are details of the toxin being used as a poison to “treat” personal enemies. This poison was produced from the powder of contaminated blood sausages.
The consequences of botulism are due to muscle paralysis. This leads to double vision, difficulty swallowing, difficulty articulating and often breathing difficulties.
Regarding medical applications, interest in the toxin first began in the 1960's. Initially it was analyzed to treat “squints”, which are a result of weakness in the muscles controlling eye movements. In 1977, the first human tests were carried out. By injecting the ocular muscles and selectively paralysis them, it was discovered that squints may be corrected. This was a dramatic breakthrough, since till that time the sole option to correct squints was through surgery.
In the 1980's the utilization of Botulinum toxin was investigated for other medical uses. Since the compound exerts a paralytic effect, the key targets for treatment were over-active muscles. Such applications included eyelid spasm, facial spasm and neck spasm. In 1989 the FDA at first approved the utilization of botulinum for the treatment of squints, facial spasm and eyelid spasm.
Only in 2002 was the initial cosmetic application of Botulinum toxin was approved. The FDA approved the use for the therapy of lines between the eyebrows (glabellar frown lines). In 2004 a new application received approval for the therapy of excess underarm sweating. Other off-label uses have also been developed. These uses include treatment of tremor, spasticity, overactive bladder, anal fissures, and headaches.
The 1st authorized make of botulinum toxin for medical use was called “Oculinum”. In 1991 the license for manufacture of botulinum toxin was acquired by Allergan and the drug was later renamed Botox.
At the same time, production of botulinum toxin was underway in Europe. At first it was manufactured at the Defense Technology and Science Laboratory in England and commercially approved in 1991 as Dysport (Dystonia Porton Products). The laboratory went through a few name changes, however it was usually bought in 1994 by Ipsen.
A Frankfurt based conglomerate (Merz), has begun selling another preparation of botulinum toxin named Xeomin . Xeomin is also obtained from botulinum toxin A, although it has been reduced in protein load and is not as sensitive to heat. While other preparations must be kept frozen, Xeomin can be stored without the need for refrigeration.
While today Allergan is the market leader, no doubt the introduction of Xeomin into the US market will lead to a shake up in the Botulinum toxin market. You can be certain that you'll be listening more about this drug.