IN the seven years since its approval for cosmetic use, Botox has succeeded in winning over the hearts and brows of many a desperate housewife — not to mention an age-defying politician or two. The wrinkle smoother has made billions for its maker, Allergan, and made it harder and harder to guess the age of news anchors. She could be 50; only her dermatologist really knows.
But this blockbuster drug may soon face fierce competition if the Food and Drug Administration approves Reloxin, another injectable made from the botulinum toxin, which has had success temporarily smoothing wrinkles in other countries.
The buzz among doctors that has been spreading in the news media and on beauty-oriented Web sites like RealSelf.com is that Reloxin works more quickly and lasts longer than the roughly four months Botox does. Dr. Leslie Baumann, a University of Miami dermatologist who did some of the clinical trials for Botox and Reloxin, recently said on NBC’s “Today” show, “It’s time that we have something that lasts a little bit longer” than Botox.
But does the truth match the early expectations for Reloxin? Much is at stake for Medicis Pharmaceutical, the American drug company that has licensed the wrinkle smoother from its French maker, Ipsen, and has conducted the pivotal trials, which have been presented to the F.D.A. for approval. So far, studies have not proven definitively that either Botox or Dysport (as Reloxin is known in Europe and South America) has an edge in terms of how long it lasts or how quickly it takes effect.
“To be honest, if you just talk about aesthetics, there are no good comparative trials on Dysport and Botox,” said Dr. Berthold Rzany, an author of “Botulinum Toxin in Aesthetic Medicine” and the director of evidence-based medicine at Charité, the university hospital in Berlin, Germany.
Only small studies exist, Dr. Rzany said, adding that at least 300 participants would be needed to prove that one of the drugs lasts longer. Choosing a longer-lasting product would matter to consumers because both drugs are expensive. In England, a visit for Botox or Dysport costs roughly $250 to $430, said Dr. John Curran, the former president of the British Association of Cosmetic Doctors. (There is no information yet about how it might be priced in the United States.)
In the run-up to Reloxin’s possible approval by the F.D.A., several doctors in England, France, Germany and Brazil, who have injected both Botox and Dysport for cosmetic purposes, were interviewed to see what could be gleaned from their years of experience.
The resounding response is that one drug doesn’t necessarily keep the wrinkles at bay longer than the other. A skilled doctor can achieve similar results with either Botox or Dysport, the doctors agreed, but at least three doctors said that Dysport was less expensive for them to use.
Dosing is at the heart of much of the controversy about which wrinkle relaxer lasts longer, most of the foreign doctors said. A different amount of Dysport than Botox is needed to tame, say, frown lines or crow’s feet, but exactly how much is still a matter of debate. If approved, Reloxin will be deemed appropriate for the area between the eyebrows, but like Botox, doctors will likely inject it in other parts of the face as well.
“Educational efforts around appropriate utilization and dosing will be massive pending F.D.A. approval,” said Jonah Shacknai, the chief executive of Medicis.
But doctors in the United States will still face a learning curve, foreign doctors said. Going from Botox to Reloxin is akin to mastering a new language.
Dr. Doris Hexsel, a researcher and a dermatologist in private practice in Brazil, said that in 2004, three years after Dysport was approved there for cosmetic use, it took her a month to become familiar with the new drug after years of working with Botox. While she used a dosage that many other doctors found to be safe for the lower face, she was not entirely happy with the outcome.
“I gave to my patients stronger results than I would like,” said Dr. Hexsel, the author of medical books about botulinum toxins. She adjusted the dosage and, she said, “patients are happier with Dysport.” She added that she doesn’t wish to promote one drug over the other.
Some doctors say there is no grounds for asserting that one drug outlasts the other.
“If anyone out there is saying that Dysport is better than Botox, they are marketing,” Dr. Curran said. “They are both very good products. They do an excellent job medically and aesthetically. By altering the dilution you can get the same effect.”
Dr. Benjamin Ascher, a plastic surgeon in Paris who specializes in botulinum toxins, feels the same way. “Reloxin is a little bit stronger, which is not necessarily good or bad,” said Dr. Ascher, who has had research financed by Allergan and Ipsen. “When you have a product that works, it matters how much you put in the injection.”
Dr. Robin Stones, a medical director at Court House Clinics, which has seven outposts in England, uses both drugs. “There are certain situations when I may choose one or the other,” but not because of “patient preference,” Dr. Stones said. “Clients don’t tell me there’s any difference.”
By contrast, Dr. Nick Lowe, a dermatologist with patients in London and Santa Monica, Calif., thinks that Botox and Dysport work differently. He capitalizes on those differences and occasionally injects both drugs in a single visit to separate areas. If a patient has prominent crow’s feet around the eyes, “where you want a little more spread,” he said, he uses Dysport, which “definitely lasts a bit longer.”
Want to tame upper-lip lines? Botox, which he said doesn’t spread as much, is Dr. Lowe’s choice. (But for his own brow, Dr. Lowe, who used to consult for Allergan, prefers Dysport. “I get a slightly more natural look,” he explained, adding, “I don’t like that Dr. Spock look.”)
The F.D.A. will most likely update Medicis in mid-April, but most analysts expect a final decision on Reloxin later this year.
IF Reloxin is approved, an injector’s expertise will matter even more, doctors said. Dr. Seth Matarasso, a dermatologist in San Francisco who lectures about Botox, said he is still shocked that some doctors know little about facial anatomy, dilution procedures and complications. A new botulinum toxin, he said, is “a concern for the neophyte or someone who doesn’t inject a lot.”
Kate Lyra, an actress living in Rio de Janeiro and a patient of Dr. Hexsel’s, found an upside to Dysport. Five years ago, she said it tamed her slight frown lines and crow’s feet for about eight months, compared with five months with Botox.
“It definitely lasts much longer,” she said of Dysport. But, if the doctor lacks expertise, she said, you could be saddled with “a very odd expression” for longer.
At this point, it is unclear whether Reloxin will be less expensive than Botox for American doctors, and whether they will pass along savings to patients. Ultimately, the prospect of Reloxin injections lasting longer than Botox may make all the difference.
Consider a patient of Dr. Ascher’s who spoke on the condition that she not be named. Dr. Ascher had treated her frown lines and crow’s feet with Botox every four months, before switching to Dysport, which she said lasts five to six months.
“I am only going twice a year,” she said, “and only paying half.”
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