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Reloxin review extended, Botox battle expected

Is a Solution for:
Sagging Skin
January 23, 2009 Reviewed by admin 0 Comments
According to USAToday, in the weeks leading up to our new president's swearing in, the nation's capital was flooded with cosmetic treatments, as expectant revelers broke out the Botox before the bubbly. With a new year come new findings and procedures, and 2009's injection du jour is Reloxin. It didn't get the OK from the FDA in 2008, but this new weapon in the war on wrinkles is primed for review this coming April.

What makes the latest aesthetic drug noteworthy, and is it better than Botox? Reloxin (aka Dysport/Azzalure) is a neuromuscular-blocking toxin that inhibits the release of acetylcholine, thus reducing muscular spasm. Like most cosmetic procedures, Reloxin evolved from a medical purpose- to treat motor disorders and forms of muscular spasticity, such as involuntary eye closure (blepharospasm), cervial dystonia, and hemifacial spasm. It was later developed for cosmetic use after tests showed that it can paralyze the muscles that cause facial wrinkles and may both act more quickly and last longer than Botox.

In Phases II and III of clinical trials of Reloxin in the U.S., the drug proved to be both safe and effective. Some patients displayed visible results in just a few days, indicating a quicker onset of action than Botox, which can take weeks for effects to show. Not only did many younger patients see a full reduction of frown lines within just 24 hours, but some patients experienced lasting correction well beyond 4 months in the forehead and brow areas. Unfortunately, older patients tended to respond less successfully, possibly due to age-related complications such as photo damage or delayed muscle response.

Though it is superficially identical to Botox, Reloxin is different in that it is suspended in lactose, whereas Botox is suspended in sodium chloride. Also, Botox is provided in 100-unit vials, as opposed to Reloxin's 500-unit vials, making the preparation less expensive for doctors- a bonus likely to be passed on to consumers. Doctors typically pay over $500 per vial of Botox, enough to treat only five different facial areas, or 1-2 patients. With the entry of Reloxin in the arena of injectable treatments for wrinkles, a marketing battle and pricing war are expected to ensue.

Officially termed "botulinum toxin type A" (since it is made from the same bacteria that causes botulism food poisoning), Reloxin was originally submitted to the FDA for approval in March of 2007, with the expectation that it would be reviewed within 10 months and ready for commercialization in North America shortly thereafter. Though the FDA confirmed that the facilities of Reloxin's manufacturer, Ipsen, are in compliance with current Good Manufacturing Practices, the drug remains in limbo for the U.S. market. It is currently approved for aesthetic use in 23 countries (Argentina, Australia, Belarus, Brazil, Columbia, Ecuador, Egypt, El Saldavor, Germany, Honduras, Israel, Kazakhstan, Mexico, Moldova, New Zealand, Philippines, Russia, Slovak Republic, South Korea, Ukraine, Uruguay, Venezuela, and Vietnam).

With the FDA's seal of approval, Reloxin will prove that it is comparable to the cosmetic gold standard that Botox has become over the past seven years. Besides longevity and price, Reloxin has shown to differ from Botox in effect, spreading farther from the injection site. In areas such as the forehead, this characteristic might be considered favorable, since it would reduce the quantity of injections required and subsequently minimize the potential for bruising. However, in areas where more precision is desired, Reloxin may not be the best solution. Ultimately, each drug might one day be used either in concert or as distinct treatments for targeted facial zones.

In 2007, Allergan posted Botox sales of $1.2 million and claimed that demand was "subdued" late last year. Economic slumps aside, people are still willing to spend the big bucks on maintaining a youthful appearance, widely considered essential to getting/keeping a job, as reported in a recent Wall Street Journal article. Bottom line: you might see results from Reloxin cheaper, faster, and longer, but not necessarily safer.

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