NEW COMPETITORS FOR BOTOX ON HORIZON

The outstanding cosmetic enhancements that Botox offers continues to be enjoyed by millions of people around the world. Botox was developed for medical purposes in the 1970s and 1980s. Originally it was developed to help the condition called Strabismus. Strabismus is when the eyes do not both look in the same direction, causing one eye to appear as though it is turned in or turned out. Dr. Alan Scott developed Botox to temporarily weaken one of the eye muscles so that both eyes could look in the same direction. Botox was approved for this purpose in the 1980s.

Soon afterwards, further medical uses for Botox were discovered. Patients who have the condition called blepharospasm constantly and involuntarily blink their eye muscles. This disease, when it progresses far enough, can prevent people from reading or driving. It can also make work almost impossible. Its devastating physical and psychological effects lower the quality of life of many people who have it. By relaxing the eye muscles, Botox greatly helps these people. Patients who could no longer drive are able to drive again. People who had difficulty reading can read again comfortably after the use of Botox for this purpose.

Soon after, roughly around 1990, related conditions were also treated with Botox. A condition similar to Blepharspasm, called Hemifacial Spasm, occurs when half of the face uncontrollably twitches. Just like Botox can be helpful in the case of Blepharspasm by relaxing the involuntary blinking muscles, Hemifacial Spasm patients can feel more comfortable in social settings because of the fact that their face is no longer twitching uncontrollably.

Other forms of so called Dystonia, where muscles involuntarily twitch throughout the body, were soon thereafter treated with Botox. Children could also benefit from this medication. Patients with spastic Dystonia who had difficulty walking or using their hands or arms were treated with Botox, and in some case could walk again.

It was recognized early on in the use of Botox that the patients who were treated for some of these conditions enjoyed reduction of wrinkles in the areas that Botox was placed. This was most noticeable in the patients who were treated on one side of their face. These patients, and their doctors, recognized that the side treated with Botox had far less wrinkles than the untreated side. When these patients repeated the use of their medications, the difference in appearance of the treated and untreated side became even more and more prominent.

Allergan, the company that makes Botox, received approval for use of Botox for cosmetic purposes in 2003. Allergan completed trials to show that the use of Botox in the glabella, the frown line between the eyebrows, could relax the frown line and improve one’s cosmetic appearance. The FDA granted approval of Botox for this purpose in 2003. Although this is the only “On-label” cosmetic use of Botox, physicians soon began to use Botox elsewhere on the face. An On-label procedure is one that is specifically approved by the FDA. However it is not only legal, but customary amd common, for doctors to use medications that are On-label for some purposes, Off-label for other purposes. Likewise, Botox was quickly used for relaxation of forehead lines, crow’s feet and occasionally on other areas in the face to reduce lines created by overactive muscle movement. There are now millions of people around the world who have been treated with Botox for these purposes.

On a chemical level, Botox is a protein derived from bacteria, Clostridium, that temporarily disrupts the signal from a nerve to a muscle. Nerves communicate with muscles, telling them to contract, using substances called neurotransmitters. These are proteins that are released from a nerve and enter a muscle telling the muscle to contract. When Botox is placed near a nerve, the nerve takes up the Botox protein and even when the nerve tries to send the signal to the muscle telling the muscle to contract, Botox overrides this signal and does not allow the muscle to squeeze. This effect is always temporary. Typically after three months or so the nerve will metabolize the Botox protein and the signal will resume as though the Botox was never there.

In the near future Botox will enjoy competition from other medications designed for the cosmetic treatment of facial lines. A medication called Dysport (also called Reloxan) is in clinical trials in United States. This medication, much like Botox, is designed to temporarily disrupt the signal from the nerve to the muscle in order to relax muscle that creates wrinkles. Nobody can say with certainty when the FDA will approve this medication. It is noteworthy that it is currently being used in Europe with consent of the European body that oversees drug approvals.

The manufacturing process for this medication is different from Botox so it is not clear if its length of action is the same as Botox. Furthermore, because its formulation is slightly different from Botox, it is not clear if it less uncomfortable or more uncomfortable to place in a patient’s facial muscles. Furthermore, the price that Medicis, the company that will have the right for distribution of Reloxan in the United States, will charge for this medication has not been revealed to the public. One must be critical when listening to estimates from the companies that develop these medications as to the timetable for FDA approval, but it is thought by the company that Reloxan will receive FDA approval in the summer of 2009 and be available for use by patients interested in cosmetic improvement shortly thereafter.

Other competitors for Botox are also in the process of developing similar medications. These competitors may not be as far in clinical studies as Reloxan, however. and may take even longer to get to the market. One such competitor is Xelmin, a Botox like product made by the German pharmaceutical company Mertz. The properties of this medication in relation to Botox have not been released to the public and we are unsure as to its advantages or disadvantages. Similarly, another product in the early to mid phases of testing is called Puretox.

Patients have enjoyed the unique and striking effects of Botox for many years. It’s mechanism of action to promote cosmetic enhancement and facial rejuvenation is a true breakthrough. It has changed how patients view surgery as many patients now have a nonsurgical alternative to improving appearance. Very soon, we will be entering a new phase of cosmetic enhancement and facial rejuvenation as these Botox competitors reach the market in the next few years. Whether they demonstrate the unparalleled safety and effectiveness that Botox has demonstrated remains to be seen. Most physicians and patients welcome the possibility of competition to the market place. It seems nothing but beneficial to have a widened array of products and prices to help patients with their choices in facial rejuvenation.