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Dysport / Reloxin


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.

 

                                  Dysport or Reloxin on CosmeticSurgeryForums.com

                                       Licensed image for CosmeticSurgeryForums.com

 

  • 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.


 

                          Packaging for Dysport

 

 

Difference between Dysport and BOTOX


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.

 

                              Image of Frown Lines or Glabellar Lines

                                      2010 Copyright ADAM, Inc. - Used with permission

 

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.

  • Dysport vial contains lactose within it, while BOTOX has glucose.

  • Dysport comes 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.


 

                             Dysport packaging and vial

 

 

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

  • Nausea

  • Temporary headaches


     

 

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.

 

Biggest Advantages of Dysport/Reloxin over BOTOX:

  • Projected lower costs in injections

  • Results are seen more quickly

  • Possibility of longer-lasting results

     

 

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.

 

 

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