Reloxin (Dysport), alternative to Botox waiting US nod

The 15% cheaper, more lasting alernative to Botox – Reloxin – is already in European markets under the brand name Dysport.

Reloxin,a low-cost and safer rival to the much-hyped Botox injection will be soon hitting major markets.

Reloxin,developed by Medicis Pharmaceutical Corp. and Ipsen SA, may be priced 15 percent lower than Botox.

Reloxin, available in Europe under the brand name Dysport, claims to be a cheaper and longer lasting alternative to Botox injectins

Reloxin injection relaxes the muscles that cause forehead lines using a type of botulinum toxin similar to the one in Allergan Inc.’s Botox.

Reloxin is already popular outside of the US under the name Dysport.

Users claim that Reloxin lasts longer, is stronger, and can produce more natural-looking results than Botox. Doctors who have worked extensively with both Botox and Reloxin have reported that while the two are relatively comparable at their relative dilutions, injectors tend to prefer one over the other for various facial areas, due to differences in the onset of, and spread of effect.

Reloxin is decidedly faster-acting and has a greater ’spread’; while Botox tends to remain more localized, allowing for greater precision and predictability in the treatment area, but may require more injections during a treatment.

However, a comprehensive understanding of internal facial musculature and physiology and an elevated risk potential (using a stronger toxin with a different mixing ratio and slightly varied treatment response) are considerations for an eager cosmetic surgeons.

Whether cost savings to the practice ultimately will find their way to the cosmetic patient will likely correspond most directly to an injector’s comfort level with Reloxin and their ability to integrate it seamlessly into their regular daily workflow.

Jeffrey Adelglass, MD, FACS, a cosmetic physician and Medical Director of SKINTASTIC Medical and Surgical Rejuvenation Center of Plano, who is currently one of the largest purchasers/injectors of Botox in North Texas and the US, advices: “With injectable cosmetic treatments, if you see an offer that seems too good to be true, do a little digging to find out why it’s so inexpensive. Sometimes it really is a quality offer by an established medical practice with injections performed by experienced, qualified medically-licensed injectors.”

“It is suggested that Reloxin results might last up to a month or even two beyond that of Botox – which could be a real bonus as long as the outcome is what you wanted; but if not, you’ll have that much longer to live with the results,” he added.

However, Reloxin is facing adelay in approval from the USFDA Medicis Pharmaceutical Corp. and Ipsen SA, are in talks with the Food and Drug Administration (FDA), Boulogne-Billancourt, France-based Ipsen said.

The FDA delayed a decision on Dysport, Ipsen’s version of Reloxin for medical uses, in December to finish work on a risk- management program to ensure safe use. Analysts have said they expected the FDA to delay Reloxin approval until later this year over questions about how the company plans to track use in order to minimize potential risks seen with other botulinum toxins.

The US FDA apporoval for Reloxin is expected to come in the second half of this year.

Reloxin is estimated to generate annual sales of $160 million by 2012.Almost 2.5 million Americans had Botox injections last year, according to the American Society for Aesthetic Plastic Surgery. The drug was approved in 1991 for medical uses and in 2002 as a wrinkle smoother. It quickly became fashionable among aging celebrities as a non-surgical way to appear younger.

Botox earned $1.31 billion for its maker Allergan in 2008, split between cosmetic use and treatment of neurological disorders. Allergan estimates it has an 83 percent share of the global market for neurotoxins that paralyze certain muscles or nerves.

The FDA warned consumers in February 2008 that botulinum toxins may spread beyond the site of the injection and cause botulism, a potentially deadly muscle-weakening illness. The greatest risk was seen with high doses of the drug, used by some doctors to treat limb spasms caused by cerebral palsy, an approved use in many countries outside the U.S.

In Europe a version of Dysport for aesthetic uses, called Azzalure is being marketed by Galderma, a joint venture between Nestle SA and L’Oreal SA.  Medicis bought rights in 2006 to develop and sell the drug for those purposes in the U.S., Canada and Japan.