Dysport Units and Dilution Versus Botox Units and Dilution: 3 to 1 will get it done.

 

As neurotoxin science continues to advance and more drugs become available, patients will be offered more choices of treatments.  Currently Botox (Allergan) and Dysport (Medicis) are the only FDA approved neurotoxins (also called neuromodulators) to treat facial lines and wrinkles.  Numerous other similar drugs are currently in the pipeline for FDA approval, including products from China and Germany.  Patients outside the USA have more options and US patients will soon have some of these options.  More options are not necessarily better options as Botox and Dysport have long track records of safety and efficacy, but these new products will more than likely also offer safety and effectiveness and may also be more cost effective for patients.

All neurotoxins will be compared to Botox in terms of safety, efficacy, time of onset and duration of the effects.  As with any new product competitor on the market, positive and negative rumors will abound that can assist or detract from the new product.  Finally, all new products will settle in to their niche based solely on their effect and not conjecture.

Dysport has big shoes to fill in taking on Allergan’s previous monopoly of Botox.  Dysport has an excellent track record in Europe where it has been an option for a decade.  Like any new drug, doctors must figure out “the right way to use it”.  More than ever before, drug companies are strapped in getting the word out by Big Pharma regulations.  Although regulation is necessary, drug companies are literally hamstrung and sometimes voiceless.  Dysport would love to tell doctors the “best way” to use the new drug, but simply are not allowed, so it rests in rumor and conjecture as the means of determining “best practices”.

The biggest question of doctors new to Dysport is “how does the Dysport dosage relate to Botox dosage.  Being a consultant for both companies, I am asked this question frequently in my teaching travels around the US.  Initially, doctors were saying that “one Botox unit should equal 2.5 Dysport units”.  Although not an official comparison, this suggested that in order to have an equal effect, a patient that would normally have 20 units of Botox to treat their frown lines would require 50 units of Dysport to appreciate the same effect.  Comparison of units are not “apples to apples” official pharmicopia, but rather convenient conversions to anecdotally arrive at a standard between the two drugs.  Unfortunately, I believe that this first round of “units to units” comparison gave Dysport the short end of the stick.  Here is the reason.  When a new drug is introduced that competes with a standing giant, patients will try it (or not try it) based on numerous factors.  These selection factors include the advice of the treating doctor, cost factors, rumored advantages, the “newness” factor and the possibility that the new drug will simply work different or better.  Herein lies the catch.  If a patient has been getting successful Botox treatments with 20 units to their frown lines and wants to try the new Dysport and their doctor gives the rumored 2.5:1 ratio (50 units of Dysport), the patient is going to be a hard line test of which one works best.  In my experience, the 2.5 conversion is not enough Dysport to produce the effect of 20 Botox units.  If so, the patient will have a less profound or shorter acting effect and Dysport will be “dissed”.  My experience (and that of other surgeons) of using 3 Dysport units for 1 Botox unit seems to be a more accurate dosage in the quest for equipotent treatment between the two drugs.  If doctors are truly interested comparing these two drugs, they must use an equipotent dosage, which I believe to be 3 Dysport units for each Botox units or 60 units of Dysport for an area usually treated with 20 units of Botox.  Failure to use this ratio may give patients a false comparison of the effects and longevity of Dysport. 

Why is all of this important?  Personally, I feel that Allergan and Medicis are both great companies and I use fillers and neurotoxins from both of them.  From a doctor standpoint, you have to offer all contemporary options to your patients and from a consumer standpoint, every Coke needs a Pepsi.  What is important is that when comparing on new product to another, it is done in a fair way for the surgeon and patient to accurately evaluate.  Having said this, I believe the fair and balanced (hey, does that sound familiar?) way to this is to inject 3 Dysport units for where you would use 1 Botox unit.  Then the surgeon and patient can fairly evaluate the drugs.  It is unfair for the company and patients to compare with a lesser amount.  You will never find an official chart that says use 3:1 and Medicis is not allowed to even think that out loud, so it is up to the experience of scientifically minded clinicians to fairly sort this out for everyone else.  I am trying to do my part and I think it is 3:1 ad nauseum. To prepare Dysport for this dilution, 3 cc of preserved saline is added to the 300 unit Dysport vial.  Five one half cc syringes are drawn up and each will contain 60 units.

To find out more about Botox, Dysport and cosmetic facial surgery in Richmond, Virginia visit www.lovethatface.com

Joe Niamtu, III DMD

Cosmetic Facial Surgery

Richmond, Virginia

www.lovethatface.com

Botox without Needles?

For over 100 years, doctors have been administering medications with needles.  I can’t think of any single factor that patients of all ages hate about seeing the doctor that is worse than the fear of needles.  Besides scaring patients, many health care workers are injured or infected from accidental needle sticks.  There is nothing fun about needles!

There are hundreds of scientists and researchers constantly working on alternate medication delivery systems to get medications in the body without using needles.  We have made good progress with numerous medications.  Patients with chronic pain are able to get pain medication from patches applied to the skin and numerous other medications can be administered in this manner.  I predict that in the future, we will even be able to provide general anesthesia without needles or tubes in ones throat.

A topical, non injectable form of Botox (botulinum toxin A) is impressing researchers and is in phase II clinical trials. Revance Therapeutics is a private company in Mountain View, California that has developed a gel that is mixed with the Botox or Dysport that allows large macromolecules to cross the skin and provide local and targeted treatment of the muscle that causes “crow’s feet” wrinkles.  The company calls this technology TransMTS (macromolecule transport technology) and this technology is based on a single, straight-chain peptide that allows the skin to accept the medication instead of preventing absorption.  To get a bit more technical, adding a peptide as a separate component to the neurotoxin allows the medication to cross the skin. The peptide is said to form an ionic bond with the toxin and the peptide also has a protein transduction domain (PTD) which allows the medication to penetrate the skin.  The protein carrier featuring (PTD) holds on to the cell membrane and allows larger molecules to pass.   Currently, there have been over 600 crow’s feet regions treated with this technology with impressive clinical results and without complications.  Studies are also in place to use this topical application to the under arms for control of sweating.

No mention has been made of how long the treatment takes or how long it lasts and there will certainly be variables that effect results in given patients.  In any event this new technology is very exciting and representative of what the future holds for painless application of medicines.  This would be a very welcome addition in the cosmetic facial surgery arena.

To find out more about Dr. Niamtu and cosmetic facial surgery in Richmond, Virginia visit www.lovethatface.com

 

Joe Niamtu, III DMD

Cosmetic Facial Surgery

www.lovethatface.com

Dysport: the new “Botox”

If Allergan’s Botox is Goliath, then Medicis and their new neurotoxin is David.  No one can argue that Botox has enjoyed a monopoly in the United States for past 15 years.  After all, Botox was a true paradigm shift in cosmetic surgery.  Never before, without surgery, could a patient have wrinkles disappear.  The introduction of Botox was something so different and so easy that it truly heralded in a new era known as minimally invasive surgery.  What began as a “pretty poison” has grown into “cosmetic maintenance” and now women and men get regular Botox injections with the same regularity that they get their hair colored or teeth cleaned.  Botox has not only continued to be safe and effective, but has gone on to treat many conditions from headaches to hemorrhoids.

Botox has gone largely unchallenged and Allergan has become a corporate giant due to its sales.  Second to Viagra it is the largest selling drug.  A brief challenge came in the “at the turn of the last century” with Myoblock, a similar product but chemically different.  Unfortunately for Myoblock, it did not live up to the effectiveness of Botox, and its popularity was short lived.  It is still used for the few patients that have a resistance to Botox, but is a small player.

Dysport is chemically very similar to Botox and has been used in the United Kingdom for 15 years.  It varies from Botox in its biochemistry and protein structure but basically does the exact same thing.  This drug has recently received FDA acceptance and will be sold in the United States under the same name.  Dysport will make a big bang with the media upon it final FDA acceptance and rumors will fly.  The Dysport FDA trials showed that Dysport took effect somewhat faster than Botox and basically lasted the same amount of time, about three months.  Why challenge the king of neurotoxins (more politically correctly called neuromodulators) with a drug that basically does the same thing.  I call it Coke versus Pepsi marketing.  Consumers and surgeons desire choices in everything from clothes, to cars to, carpet and want choices.  There is also some bragging rights from being the “new kid on the block” (just ask Red Bull).  Cosmetic consumers and media are fascinated by “new” technology and if it is new then it must be better.  Frequently this does not pan out, but a well marketed and effective competitor can certainly gain market share.  When all the US automakers were getting bailed out by the Federal government, Toyota (who was a newcomer to this country) remained strong.

To cut to the chase, Dysport is exciting because it is new and is also taking on heavyweight Botox.  It is likely to become a popular competitor.  What remains to be seen, and could make the difference in the wrinkle wars, is how Dysport is priced in comparison with Botox.  If Medicis significantly undercuts Allergan, Dysport could potentially displace the king.  I doubt that this will happen as corporate America is not fond of less profit.  A similar scenario occurred with Restylane, the revolutionary lip and wrinkle filler from Medicis.  This was the first new filler that was FDA approved and made a meteoric rise to the top of facial injectables.  There was no significant competition for about 4 -5 years until Allergan obtained FDA approval for Juvederm.  In the pre release period, much speculation occurred as to whether Allergan would significantly undercut the pricing of Restylane.  Guess what?  They did not.  Their pricing was almost identical and Juvederm no doubt took a chunk out of the filler sales dominated by Allergan.  Competition is generally a good thing as it offers the public more choices and can sometimes drive down prices, but don’t look for this with aesthetic companies.  They figure if patients will spend $500 for X, then they will spend it for Y.  Time will tell.

To find out more about Botox, Dysport and other cosmetic facial surgery procedures, visit www.lovethatface.com.

 

Joe Niamtu, III DMD

Cosmetic Facial Surgery

Richmond, Virginia

www.lovethatface.com