Get Ready–Here Comes a New Type of “Botox”
Is there a new, quicker-acting alternative to Botox®?
A study on a new type of botulinum toxin type A for treating facial wrinkles was published in the March/April 2009 issue of Archives of Facial Plastic Surgery. The article, titled “Long-term safety and efficacy of a new botulinum toxin type A in treating glabellar lines”, details the results of a Phase 3 study (for explanation of FDA study phases, see here) of patients who received a new type of botulinum toxin type A, called Reloxin. The primary goal of the study is the evaluate the long-term safety of repeated administrations of Reloxin in treating the frown lines between the eyebrows (glabellar lines). Secondly, the study sought to determine how well Reloxin works (effectiveness and duration).
The study was a multi-center trial, involving 21 separate sites across the United States. Twelve hundred patients were enrolled, and each patient received at least 1 treatment with 50 units of Reloxin. Four more treatment cycles followed, and in each cycle some patients were dropped from the study (for a variety of reasons). In the end, 177 patients received five full treatments of the glabella with Reloxin.
Adverse events are recorded in this type of study, and range from the somewhat innocuous or expected to the more serious. In this study, the most common events were ‘injection site events’ which occurred in 18% of patients. According to the authors, these were generally considered ‘mild to moderate’ events. The second most common events were headaches, and these occurred in about 15% of subjects. Finally adverse events around the eye were reported in 9% of subjects, and typically resolved within 3 weeks. The exact types of events were not defined, though the authors did point out that ‘ptosis’ (drooping of the eyelid or brow or both) occurred in about 1.3% of subjects, which is comparable to Botox®.
The effect of Reloxin was seen typically around 3 days after injection, and as soon as 1 day in some subjects. Contrast this with Botox®, in which the effect is typically observed at around 5-7 days (though it may start earlier). Duration of effect was typically around 90 days, which is comparable to Botox®. No reduction of effect was noticed in subjects who underwent repeated treatment. In other words, there was no development of reduced response over time (or resistance to Reloxin).
What does this mean for you? It may mean that a new type of injectable botulinum toxin type A is around the corner. Reloxin showed similar duration of effect as Botox®, and seemed to show its effects more quickly. Complications of treatment were similar to its long-used cousin. Of note, Reloxin has been in use in Europe for 15 years (where it is called Dysport). Bringing this drug to the United States will mean more options for patients who would like to treat wrinkles in the upper face.
It should be noted that the study was funded by Medicis, the company that manufactures and plans to market Reloxin in the United States. Furthermore, one of the study’s lead authors disclosed that he owns stock in, has been a consultant for, and has received research support from Medicis.
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