Dysport/Reloxin is a "new"
injection that is being marketed and is currently under review by the FDA for
distribution and utilization within the United States. Dysport/Reloxin is another brand of
Botulinum Toxin Type A, the same ingredient that is found in BOTOX. This other
product has been available in Europe for a few years and is currently been
marketed as Dysport.
Dysport/Reloxin is not a new
neurotoxin because it has been used in Europe for at least over a decade for
neurological conditions. In the United States, Dysport/Reloxin has been undergoing
clinical evaluation for the last 5 years, and it is now approved for use by the US Food and Drug Administration.
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Dysport like BOTOX prevent the
pre-synaptic transmission of acetylcholine into the synaptic cleft thus
preventing muscle contraction.
The results of this injectable will last
approximately 4-6 months and the injection needs to be repeated to see continued
effect and enjoy the cumulative effects of the product.
Dysport; was recently acquired by
Medicis Pharmaceutical Corporation which is located in Scottsdale, Arizona.
Medicis is now part of Johnson & Johnson.
Dysport/Reloxin however has been in use
since 1991, in over 23 countries.
There are some slight variances in the treatment formula of Dysport and BOTOX.
Both use botulinum toxin type A; however,
BOTOX is alleged to have higher
protein concentrations in its treatment doses than Dysport does. Consequently,
Dysport is estimated to produce fewer antigens that destroy foreign substances
or toxins. Because of this factor, Dysport results may last longer than BOTOX.
BOTOX is provided in 100-unit vials, as opposed to Dysport 500-unit vials.
Because of the difference of the units per vials, both Dysport and BOTOX are not
remotely the same, so the dosage is completely different. 1 unit of BOTOX is
approximately equal to 2.5-3 units of Dysport/Reloxin. There are a couple of conversions
that physicians use, such as 2.5:1 or 3:1.
Several studies showed that 2.5:1
was ineffective in certain situations, while 4:1 ratios led to adverse events.
The studies performed were done with frontal muscles and showed less activity in
the 2.5:1 ratio, but increased muscle weakness in the hand when used for
hyperhidrosis (excessive sweating) in the higher ratio of 4:1.
These differences include onset of action, side effects -- or spread -- of the
toxin, duration, and safety. The area that's most commonly used for both testing
and injecting is the glabella, or the frown line. There are five muscles
surrounding that area that can be safely injected, which will relax the muscles
by inhibiting the neurotransmitter and will eliminate the frown line and the
surrounding wrinkles.
Since Dysport/Reloxin purportedly has lower protein concentrations in its solution than
BOTOX does, the formula is said to spread more easily during treatment. This
effect could create positive or negative treatment results depending on the area
being treated, and might require more precision on the part of the cosmetic
provider. This mode of action is a benefit in that the large muscle groups that are in need of
injection (such as the forehead or the armpit areas) will require fewer
injections due to the spreading. This in turn will actually have a less
likelihood of potential discomfort, swelling, and bruising for the patient.
The disadvantage to the spreading
is that unless the Physician is an experienced injector with a good
understanding of more complex musculature (around the eyes, between the
eyebrows), the Dysport/Reloxin could spread into unwanted areas causing untoward side
effects (blurry vision, droopy eyebrows).
Once reconstituted -
Dysport/Reloxin has an 8-hour length of usage, versus 4
hours for BOTOX.
Dysport can be stored in the refrigerator rather than the freezer.
Dysportvial contains lactose within it, while BOTOX has glucose.
Dysportcomes in 300 unit vials as opposed to BOTOX in 100 unit vials.
The most important question regarding safety of these toxins is if
Dysport/Reloxin has
the same adverse reactions and if so, are they greater in frequency. There has
been a “Random Variable Dosage Trial” performed with Dysport/Reloxin using not only 50
units, but also 60 -80 units as well. The conclusion of this trial found that
there were no significant adverse reactions related to particular dose in
treatment.
Another safety factor studied was the development of antibodies, in which
Dysport/Reloxin showed that there were no significant antibodies found. Neutralizing
antibodies develop in some patients showing a decline in neurotoxin treatment
efficacy because of the neutralizing antibodies.
The one side effect that most people are concerned about is a droopy eyelid or
eyelid ptosis. When you inject the
glabella, if the product has significant
spread – then the possibility of the product going into the areas of the brow
could cause upper eyelid ptosis. According to the total combined percentage of
eyelid ptosis with Dysport/Reloxin studies was well below 2.1%, which is below the rate
in any of the other clinical trials that were done before.
Studies performed with “re-treatment” of
Dysport/Reloxin showed that it was less
effective on the number of treatments done or if the adverse side effects
increased. Conclusions showed that the adverse events decreased as the trials
went on, and effectiveness did not diminish.
In a variable dosage study was done to test the efficacy of
Dysport/Reloxin on men
versus women. The difference in men and women is the size of the muscle mass,
and someone with a large glabellar muscle mass will require more units of
Dysport/Reloxin. A small muscle mass in a female patient got 50 units, a medium muscle
mass ended up with 60 units, and a large muscle mass 70 units. Early in the
study when the men were dosed the same as the women, males did not respond as
well to the toxin compared to a woman with a smaller muscle mass. If variable
dosing is done, the males did equally as well as the females with a greater than
90% responder rate. The onset stayed the same and the duration in males seemed
to be a little longer.
Dysport/Reloxin was found to be well tolerated. There was no increase in adverse side
effects with dose increases. There was a very low rate of side effects,
including a low rate of ptosis. The adverse events even decreased with repeated
treatments, and no neutralizing antibodies were found.
Like BOTOX,
Dysport/Reloxin has the same possible side effects. For the most part, the
side effects associated with the treatments of wrinkles with Dysport/Reloxin are
generally mild and almost non-existent.
Side Effects Experienced:
Burning Sensation at the site of the injection
Swelling and or Bruising
Local numbness in the area surrounding the injection
Dysport/Reloxin treatments are rumored to
be marketed in the $300 range, while BOTOX injections currently average $300-500
per treatment, enough to treat only five different facial areas, or 1-2
patients. Pricing on Dysport will be approximately the same as BOTOX.
The demand for lower costs on cosmetic treatments is becoming more to the
forefront, especially in the current state of the economy. All of this will have
some sort of impact on the future sales of Dysport/Reloxin or BOTOX Cosmetic.
Dysport/Reloxin is
approximately 1/3 the cost and about 1/3 the strength of BOTOX, which means you
will need about three times as many units to get the same result. Just having a
new competitor on the market will probably help drive down some of the cost
factors with BOTOX.
Dysport/Reloxin comes in 300 unit vials as opposed to BOTOX in 100 unit vials. This
makes the preparation much less expensive for physicians, which will be likely
passed on to the consumers.
Clinical trials have show that the onset of
Dysport/Reloxin was different from BOTOX.
The median onset for the Dysport/Reloxin was between 2 to 3 days, which was noted by the
patients participating in the study with a diary of when they saw the first
signs of Dysport/Reloxin working. In some patients it was as early as 24 hours. The
duration was 4-5 months.
BOTOX lasts between 3 to 6 months, with Dysport/Reloxin lasting between 4-5 months.
Several studies have been compared Dysport/Reloxin to BOTOX in terms of longevity. One
study, which was not biased by support from either company, revealed that
Dysport/Reloxin actually lasted longer then BOTOX. However, other research studies have
shown the opposite. Some of the clinical trials initially showed the treatment
cycles did not decrease with Dysport/Reloxin, but in fact increased. Dysport/Reloxin duration
was approximately 118 days.
So the final determination is open for discussion on what product will last
longer, as the test of time will help in making the final resolution regarding
the longevity or duration of Dysport/Reloxin.
Some doctors from Europe report that the
Dysport/Reloxin starts working faster and lasts
longer. Some reports claim that Dysport/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 Dysport/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.
Some have stated that Dysport/Reloxin’s
results are more immediately visible, allegedly eliminating wrinkles within 1-2
days, rather than BOTOX's average of 3-5 days. Why Dysport/Reloxin treatments could
produce an effect more readily than BOTOX can isn't quite explained.
Dysport/Reloxin injections, like BOTOX
injections, will prove highly effective against facial wrinkles, frown lines and
forehead creases. The fact that Dysport/Reloxin utilizes the same neuromuscular blocking
toxin as BOTOX indicates it will be able to treat wrinkles in much the same way.
Allergan who manufacturers BOTOX has stated that Dysport/Reloxin does not work as well
as BOTOX. They also suggest that Dysport/Reloxin may be more likely to cause antibody
formation, which would make future treatments with either product fail.
Dosing is different than BOTOX, so the physician needs to remember the
conversion rate.
