FDA Still Working Out Wrinkles in New Drug to Compete With Botox

The Food and Drug Administration has delayed approvals for Reloxin, a new drug that is billed as being a cheaper rival to the blockbuster wrinkle-busting cosmetic drug Botox.

Reloxin injections relax muscles in the forehead to reduce the appearance of facial lines and creases, much like Botox does. However, Reloxin will be about 15 percent cheaper than Botox and some estimates say the new drug could earn its makers, Medicis Pharmaceutical Corp and Ipsen SA, about $160 million in its first few years on the market.

Drug is Sidelined, But for How Long?
The FDA is currently working on approving Reloxin in the United States for both cosmetic and medical uses, but that process hit a bump which could put plans on hold for at least a few weeks, officials said. The FDA had been set to issue a ruling on whether to approve Reloxin by this week.

However, some watching the Reloxin approval process say the drug could now be shelved until later in 2009, due to lingering concerns about how the drug companies behind the drug plan to handle potential risks that have plagued other botulinum-based toxins.

Other Similar Drugs Also on Hold
Last year, the FDA put off a decision on approval for Dysport, another Botox knock-off drug, so that more work could be done to assess the risks and benefits of the drug. The FDA is now expected to rule on Dysport for use in medical conditions by the end of May 2009. Approvals for aesthetic treatments would follow that initial go-ahead.

Botox has been the treatment of choice for millions of Americans looking to decrease the appearance of facial lines and wrinkles. More than two million people got Botox injections in the United States in 2008, earning Botox’s maker, Orange County, Ca.-based Allergan, an 80-percent share of the market for drugs that paralyze specific muscles and nerves to reduce skin wrinkles.

Botox also is approved and used to treat muscle spasms caused by multiple sclerosis, excessive sweating, twitching of facial muscles, and other non-cosmetic uses.

Drugs Not Without Serious Risks
With so much money to be earned in the cosmetic and medical uses of such products, it only figures that other suitors such as Dysport and Reloxin would emerge from the wings to seek a piece of the pie. However, botulinum-based products are not without risks.

The FDA recently warned users about the threat of the paralyzing effects spreading beyond the injection site, halting the movement of muscles necessary for breathing and swallowing. In some cases, children treated with high doses of Botox for muscle spasms have died after migration of the paralyzing effects of the drug stopped their breathing.

Botox and its competitors are billed as easy, quick ways to look more youthful, but the drugs must be approached cautiously. Such products are more susceptible to abuse by patients and their doctors, who use them in ways or in doses that are unsafe and not FDA approved.

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