Here’s another piece of news which will cheer you up: there’s a new wrinkle removing drug on the market called Dysport, distributed by Medicis Pharmaceuticals and its partner Ipsen. Dysport was approved by the US Food and Drug Administration in April 2009, and it became the second drug to compete in the anti-wrinkle market which till now has been dominated solely by Allergan’s Botox.
Don’t be too quick to make the change yet. Despite both drugs being botulinum toxin type A, they both behave quite differently, according to Allergan’s Chief Executive David Pyott. Both are not interchangeable because both drugs are dosed and injected differently.
COMPARISON BETWEEN THE 2 DRUGS
Similarities between both drugs:
- Both contain the same active ingredient Botulinium toxin type A, so producing the same effects, which act to temporarily paralyze facial muscles, hence reducing the appearance of facial wrinkles and frown lines. There is another similar drug, Myobloc produced by Solstice Neuroscience, which uses botulinum toxin type B. Myobloc is currently restricted to medical uses and not approved for cosmetic use.
- Both are locally injected into the problematic site.
- Both have been in use for many years. However, Botox was the sole anti-wrinkle drug in the US market, while Dysport, although not available in the US before, was used in Europe, South America and New Zealand since the 1990s.
Now the differences:
- Although the active ingredient is the same, and side effects are similar like muscle weakness or paralysis, respiratory difficulties and infections, swallowing and speech impairment, nose and throat irritation, pain and injection site skin reaction, eyelid swelling or drooping, headache, vision problems, nausea. There is a risk that Dysport appears to spread further around the injection site, which may be a good thing as a larger facial muscle area like the forehead can be targeted for antiwrinkle treatment, but may not be so good for small muscles. Along with it is a higher risk of disseminating and having effects elsewhere in the body.
- The preparation also differs- Dysport can be diluted and the concentration intended for use adjusted, unlike Botox. This may translate into more affordable anti-wrinkle treatment.
- Dysport is also supposed to show results earlier (in 2-3 days opposed to 1 week for Botox) and have a longer lasting effect as compared to Botox, and patients required just two treatments per year in contrast to four times per year for Botox.
Generally, the doses of botulinum toxin used in cosmetic medicine is in smaller doses than those used for medical purposes, and are usually safe when used as directed. The danger lies in patients who receive multiple injections in cosmetic use to treat wrinkles. Along with the announcement of the approval of Dysport, the FDA also announced the requirement of a black box label for all botulism based drugs, including Dysport and Botox, to warn users of the rare but potentially serious and life threatening complications in the event of the drug spreading from the injection site to other parts of the body. This came about in light of reports of hospitalizations and deaths attributed to botulinum toxin poisonings in adult and children receiving botulinum toxin A for treatment of abnormal muscle movement diseases, and petition by the Public Citizen (a health advocacy group).
The black box label is a safety alert, which requires
- users to be informed about the potential for the drug to spread to distant sites in the body and having undesired effects there
- warn doctors and patients about risks associated with substituting one botulism product for another. The products have different dosing units, and may lead to overdosing if not correctly administered.
- Follow a group of children and adults using Botox, Myobloc or Dysport off label to treat involuntary muscle movement and submit the safety data to the FDA.
DYSPORT RESEARCH
Clinical trials involving about 2900 people were conducted. A study showed 93-95% of participants noticed an appearance of forehead wrinkles within 7days after treatment, and multiple treatments produced effects that lasted more than 13months.
Dysport has been used and reviewed clinically. A retrospective study of 4103 treatments in 945 patients showed a favourable safety profile and effectiveness of drug usage.
Comparison of Botox against Dysport has also been done, with a mixture of resuts- some show botox being longer lasting, others point to Dysport having a longer effect. In a study comparing the two drugs for glabellar (the area between the eyebrows) lines (at dose of Botox 20U and Dysport 50U), both produced similar efficacy at weeks 8 and 12, but Botox offered a significant duration of activity at week 16. However, it was a small study with 62 patients. Another study with 26 patients (dose Botox 12U and Dysport 36U) for forehead wrinkles found Dysport to have longer lasting effects between weeks 10 to 20. The
MEDICAL USES OF BOTULINUM TOXIN
Botox is the most commonly performed aesthetic procedure in the USA, with over 2.5million injections in 2008 alone. It has a large following and a high satisfaction rate among users. Originally developed in 1968 for use in the field of ophthalmology for strabismus (crossed eyes), it is now also used for
- cervical dystonia
- muscle spasms in cerebral palsy
- eyelid spasm
- severe underarm sweating
Dysport is targeted for use not just for cosmetic purposes to treat wrinkles. It is also planned for usage for cervical dystonia. It should be available for cosmetic use in the next 2-3months, and for medical purposes in the second half of this year. Word is that the new botulinum drug will be marketed at a lower price than Botox.
There’s talk of botulinum toxin in the form of a cream- after all, if the injections have been met with such success, imagine if it can be administered as a cream! But there’s controversy over the efficacy and absorption of a cream based botulinum toxin, and more research is required. And that’s another article altogether!
Here’s another piece of news which will cheer you up: there’s a new wrinkle removing drug on the market called Dysport, distributed by Medicis Pharmaceuticals and its partner Ipsen. Dysport was approved by the US Food and Drug Administration in April 2009, and it became the second drug to compete in the anti-wrinkle market which till now has been dominated solely by Allergan’s Botox.
Don’t be too quick to make the change yet. Despite both drugs being botulinum toxin type A, they both behave quite differently, according to Allergan’s Chief Executive David Pyott. Both are not interchangeable because both drugs are dosed and injected differently.
COMPARISON BETWEEN THE 2 DRUGS
Similarities between both drugs:
Now the differences:
Generally, the doses of botulinum toxin used in cosmetic medicine is in smaller doses than those used for medical purposes, and are usually safe when used as directed. The danger lies in patients who receive multiple injections in cosmetic use to treat wrinkles. Along with the announcement of the approval of Dysport, the FDA also announced the requirement of a black box label for all botulism based drugs, including Dysport and Botox, to warn users of the rare but potentially serious and life threatening complications in the event of the drug spreading from the injection site to other parts of the body. This came about in light of reports of hospitalizations and deaths attributed to botulinum toxin poisonings in adult and children receiving botulinum toxin A for treatment of abnormal muscle movement diseases, and petition by the Public Citizen (a health advocacy group).
The black box label is a safety alert, which requires
DYSPORT RESEARCH
Clinical trials involving about 2900 people were conducted. A study showed 93-95% of participants noticed an appearance of forehead wrinkles within 7days after treatment, and multiple treatments produced effects that lasted more than 13months.
Dysport has been used and reviewed clinically. A retrospective study of 4103 treatments in 945 patients showed a favourable safety profile and effectiveness of drug usage.
Comparison of Botox against Dysport has also been done, with a mixture of resuts- some show botox being longer lasting, others point to Dysport having a longer effect. In a study comparing the two drugs for glabellar (the area between the eyebrows) lines (at dose of Botox 20U and Dysport 50U), both produced similar efficacy at weeks 8 and 12, but Botox offered a significant duration of activity at week 16. However, it was a small study with 62 patients. Another study with 26 patients (dose Botox 12U and Dysport 36U) for forehead wrinkles found Dysport to have longer lasting effects between weeks 10 to 20. The
MEDICAL USES OF BOTULINUM TOXIN
Botox is the most commonly performed aesthetic procedure in the USA, with over 2.5million injections in 2008 alone. It has a large following and a high satisfaction rate among users. Originally developed in 1968 for use in the field of ophthalmology for strabismus (crossed eyes), it is now also used for
Dysport is targeted for use not just for cosmetic purposes to treat wrinkles. It is also planned for usage for cervical dystonia. It should be available for cosmetic use in the next 2-3months, and for medical purposes in the second half of this year. Word is that the new botulinum drug will be marketed at a lower price than Botox.
There’s talk of botulinum toxin in the form of a cream- after all, if the injections have been met with such success, imagine if it can be administered as a cream! But there’s controversy over the efficacy and absorption of a cream based botulinum toxin, and more research is required. And that’s another article altogether!