Since 2007, there have been rumblings in the cosmetic enhancement world about a first-ever competitor emerging for BOTOX® Cosmetic, the current industry leader in wrinkle removal. By late 2009, Reloxin®, a new botulinum toxin type A injection, also known as Dysport, will have likely received its FDA approval to be distributed in the U.S. as a cosmetic treatment. But how will it measure up against Botox's solid wrinkle-zapping reputation? Is Reloxin any more effective, safer or more cost-effective than Botox? Before we determine Reloxin's odds to sway long-term Botox supporters, let's take a look at how both of these botulinum toxin wrinkle treatments came to be.
BOTOX® Cosmetic injections paid their dues for many years before making it to the top of the non-surgical aesthetic industry. The botulinum toxin type A was first refined and used for clinical purposes in the 50s and 60s. Originally, botulinum toxin injections were administered as a muscle relaxant, and to treat monkeys with crossed eyes. It soon graduated to treating humans with the same symptoms, and was being tested in its ability to correct spasms in facial muscles and the vocal cords. In 1988, distribution rights to the botulinum toxin type A were purchased by Allergan, a large medical and pharmaceutical company. About a year later, Allergan received FDA approval to market the botulinum toxin as a treatment for spasms and eye muscle irregularities and coined the name Botox.
Into the 90s, Botox became more heavily researched and started receiving attention for relieving conditions like cerebral palsy and hyperhidrosis. Botox wasn't seriously considered for aesthetic purposes until a married couple, an opthalmologist and a dermatologist, published a study on the coincidental benefits Botox had on patients' aging skin as well as on their eyes. In 2002, BOTOX® Cosmetic became officially FDA-approved for frown lines, and in 2004, Botox was approved for treating excessive underarm sweating. Today, BOTOX® Cosmetic is one of the most popular aesthetic treatments in the world. According to the American Society for Aesthetic Plastic Surgery (ASAPS), BOTOX® Cosmetic is currently the top non-surgical cosmetic treatment in the country, and was performed over 2.7 million times in 2007 in the U.S. alone.
Since it's clear that Botox solidly established itself over many decades, and went through scores of trials and clinical research to become the best, does newcomer Reloxin® stand a chance? Reloxin's story begins with Dysport, also a botulinum toxin type A complex. Dysport was first used in the United Kingdom in the early 90s for muscle spasms and movement disorders, and it's currently the cosmetic brand name for Reloxin's formula in Europe and South America.
Reloxin® was originally manufactured by Ipsen, an international pharmaceutical company with research and development facilities in London, Barcelona, Boston and Paris. In March of 2006, Ipsen joined up with Medicis, the U.S. pharmaceutical company behind Restylane and Perlane, to develop and market Reloxin in the U.S., Japan and Canada. By October 2007, Ipsen had gained approval to market its botulinum type A toxin (Dysport) for aesthetic treatment in 21 countries, including Australia, Brazil, Germany, Mexico and Russia. Ipsen and Medicis took the next step in March of 2008, and submitted a Biologics License Application (BLA) for Reloxin to the FDA for approval. While there were some initial issues getting the process started, the FDA has now set the approval filing date for April of this year, and if all goes well, Reloxin could be hitting cosmetic clinics by late 2009.
First off, both Botox and Reloxin are neuromuscular blocking toxins that utilize the botulinum toxin type A in their injections. They are both reported to eliminate frown lines and facial wrinkles through paralysis of the facial muscles, albeit temporarily, and they are both backed by huge pharmaceutical and medical juggernauts. How can we determine which dermal injectable is better? Or decide which will be more effective as a wrinkle remover? Not to mention which one will stand the test of time in the often volatile cosmetic industry? It will be hard to make definite estimations about Reloxin's staying power until its FDA approval goes through and distribution begins. But so far, trials haven't yielded any red flags, and the FDA has already reported that Reloxin is being developed in compliance with Current Good Manufacturing Practices (CGMPs).
The word is that Reloxin® will boast lower costs, and that this could provide its greatest advantage over Botox right out of the gate. Reloxin treatments are rumored to be marketed in the $300 range, while Botox injections currently average $300-500 per treatment. The reason for its lower cost could be due to the notion that Reloxin's solution is more diluted than Botox's, thus costing less per unit of treatment. Whether these prices will remain fixed after Reloxin hits the market is yet to be seen, but the demand for lower costs on cosmetic treatments, especially in the current state of the economy, is sure to have an impact on the future sales of both wrinkle treatments.
In addition to the supposed cost difference between the two wrinkle treatments, there are also some slight variances in the treatment formula of the two. While both use botulinum toxin type A, Botox is alleged to have higher protein concentrations in its treatment doses than Reloxin does. Consequently, Reloxin is estimated to produce fewer antigens that destroy foreign substances or toxins, in which case, Reloxin's results may last longer than Botox's.
Another aspect of Reloxin's formula that's come up in the debate is its supposed propensity to "spread out" after treatment. This characteristic of the Reloxin injections, if true, could either prove beneficial or disastrous. On the one hand, spreading out of the toxin could mean seeing better results in larger treatment areas. On the other hand, the toxin could unfortunately spread to unwanted areas if not monitored or administered correctly, leading to odd distortions of musculature around the eyes and other areas.
Some reports claim that Reloxin injections will last longer (at least five or six months) based on the treatment's protein concentration and thus its lower antigen production. However, clinical trials for both Reloxin and Botox have indicated that stronger concentrations, like those in Botox, are successful at producing longer-lasting results. The bottom line is that length of effectiveness for both treatments reportedly falls in the 3-6 month range. Thus, comparative differences in the length of results won't be available until Reloxin begins its distribution in the U.S.
A final supporting claim for Reloxin is that its results are more immediately visible, allegedly eliminating wrinkles within 1-2 days, rather than Botox's average of 3-5 days. Why Reloxin treatments could produce an effect more readily than Botox can isn't quite explained. It is yet another Reloxin selling point that will have to be proven with time.
Although we have limited information about Reloxin prior to its distribution, the odds seem good that Reloxin injections, like Botox injections, will prove highly effective against facial wrinkles, frown lines and forehead creases. The fact that Reloxin utilizes the same neuromuscular blocking toxin as Botox indicates it will be able to treat wrinkles in much the same way. At this time, the biggest factors Reloxin seems to hold in its favor are projected lower costs for injections, purported greater immediacy of results, and a possibility of longer-lasting results. Again, time will tell whether Reloxin can knock Botox from its long-held position as the anti-aging gold standard, but even if it does, you can bet Botox won't be going down without a fight. For more information about wrinkle treatments or Botox injections, consult with your local cosmetic provider.