Reloxin: New Tox on the Block

March 23, 2009— -- Jennifer, a 49-year-old teacher from Chicago, sticks to a tight budget on purses and shoes -- but not Botox.

"It's a choice," explained Jennifer, who requested that her last name not be used to preserve her privacy.

She has viewed the wrinkle-busting jabs as a worthwhile splurge for nearly seven years, receiving injections every four months.

But it is an expensive choice. Botox -- the brand name for Allergan Inc.'s formulation of botulinum toxin type A -- is pricey for patients, in large part because physicians pay more than $500 to obtain a single vial of the popular drug. One vial may be barely enough to treat the facial lines of two patients.

And even as the popularity of the injectable cosmetic procedure has increased -- with the American Society for Aesthetic Plastic Surgery estimating that 2.46 million procedures were carried out in the United States last year -- so have the costs.

So when news of Reloxin, a possible rival to Botox, surfaced last week, some surmised that the newcomer may challenge its more established predecessor with a lower price tag and similar results.

Reloxin, which is now used for cosmetic purposes in about two dozen countries, would first require approval from the Food and Drug Administration, which could render a decision as soon as the second half of this year.

Jennifer's plastic surgeon, Dr. Otto Placik, said that if this approval comes to pass, its lower price point could be attractive to patients and doctors alike.

"There is antipathy toward Allergan from the physician's standpoint," Placik said. "Allergan has taken advantage of their monopoly. Botox has gone up in price every year, [which in turn] has decreased physician profit margin."

But though Reloxin contains the same active ingredient as Botox, studies have already revealed that the drugs act in subtly different ways.

"[Reloxin] disperses a little more beyond the area of injection than Botox does," noted Dr. Robert Singer, chairman of the nonsurgical procedures committee of the American Society for Aesthetic Plastic Surgery. "Because it disperses more, there has to be a greater knowledge on the part of the individual doing the injecting to avoid problems like eyelid drooping, brow drooping and other complications."

Cost of Botox May Be Big Factor, Doctors Say

And since research has shown that Reloxin is between a fifth and a third the strength of Botox, physicians who opt to use it may find themselves facing a learning curve when it comes to using the new offering.

"The dosages may not be exactly equivalent, so it might not be as straightforward as it seems," said Dr. John Canady, president of the American Society of Plastic Surgeons.

Still, for the patients who in many cases shell out several hundred dollars per treatment, cost may be a primary concern.

Dr. Brian Lester, a dermatologist in Brookline, Mass., who uses Botox in his practice regularly and has had more than five years of experience with the product, said that he felt that lower costs could be a big selling point -- particularly since the cost to physicians has risen about 20 percent to 25 percent over the last three to four years.

"I think, especially for new patients, some of that business will be moved over to this new product," he said. "I think that more competition could be good for the marketplace in terms of driving the costs down for wrinkle treatments."

Canady agreed.

"Patients who have to stretch to afford Botox will gravitate to what everyone thinks will be a lower price point for Reloxin," he said.

Allergan, however, does not look ready to budge when it comes to the price of its product.

"Entering into price wars in not something that we engage in," said Allergan spokeswoman Caroline Van Hove, who added that the costs of Botox are justified by the level of research that goes into the development of the product. "For us, it's about quality."

Medicis, the company which would market Reloxin in the United States if it is approved, offered comment on neither their product's price, nor its quality.

"Our legal team has advised us that it is inappropriate to answer any kind of media questions at this time," said Yvonne Klaerner, a spokeswoman for Medicis Pharmaceutical Corp.

The Learning Curve of Cosmetic Procedures

Lester, however, said that he would find it hard to justify switching his patients to Reloxin even if the results were similar but if savings were not involved.

"If it works the same but does not come at any discount, I don't see why we would switch our patients over. It would have to work well, but save patients money."

But those affiliated with Allergan pointed to differences other than cost that they said must be considered.

Dr. Mitchell Brin, chief scientific officer for Botox, said one of the main considerations when it comes to the potential newcomer is how it spreads, or diffuses, once it is injected. Past research on Reloxin has shown that the botulinum toxin in Reloxin tends to spread further with each jab when compared with Botox.

"The injection sites with [Reloxin] are actually different than those of Botox," he said. "When you use a new product, it's like learning a new language."

He said that because of this, the skills that doctors have developed over the years when using Botox would not necessarily translate to Reloxin -- and could even lead to unwanted side effects.

"When treating someone to get an aesthetic result, you want to put it where you want it and have it stay there," he said. "If it can spread to nearby muscles, it may have the [effect] of relaxing muscles you did not want to relax."

Brin said that if the botulinum toxin were to spread too far above the injection site, it could cause the brow to droop. If it were to drift too far below the site of injection, the eyelid could droop.

Singer, however, said that he did not predict that many of these mistakes would occur should Reloxin be approved.

"In the proper hands, I don't think you will see many of [these cases]," he said. "You might see effects like that with Reloxin with someone who has used Botox but does not have the appropriate knowledge about Reloxin. In time, it will even out."

And Canady said that professional organizations would likely step in to help educate member physicians on proper technique.

"[ASPS] will take the lead in education and making sure our members understand the differences," he said.

Will Patients Make a Switch from Botox?

Lester agreed, noting that he is confident that if, indeed, Reloxin wins approval, doctors will quickly learn how to use it safely and effectively.

"I think that at the end of the day, [clinicians] will get insight and knowledge about the product as it comes into use in the U.S."

However, since Botox works well, physicians may initially stick to what they know.

"I think until there is good widespread familiarity and feedback about Reloxin, there will always be those who cling to the 'tried and true.' Contrarily, there are always those who jump on the bandwagon of the next new product," said Dr. Carl Washington, associate professor of dermatology at the Emory Clinic in Atlanta.

Furthermore, while cost may be a concern for patients, it doesn't seem to be altering their behavior.

"I cannot think of an instance where a patient declined Botox due to its cost," Washington said.

Still, there is always the possibility that there may be newcomers to the skin injection scene.

"If [Reloxin] is cost-effective for the same results, then it will carve out a specific niche in that marketplace," Singer said. "I think that among physicians who are well-trained, board-certified plastic surgeons and dermatologists, many will offer both. People like menus of options. Of course, all of these things only time will tell."

But would a dedicated Botox fan, like Jennifer, actually switch to a less costly alternative?

"The only way I would consider it would be if Dr. Placik recommended it," said Jennifer.

Placik, in turn, said his bottom-line consideration is equally simple: "What is the patient going to ask for?"