FDA gives new injectable a thumbs up
September 12, 2011
Individuals who want to decrease the appearance of fine lines and wrinkles on their faces will soon have another option when it comes to injectables.
The U.S. Food and Drug Administration (FDA) recently approved the drug Xeomin for temporary improvement in the appearance of moderate to severe glabellar - or frown - lines, according to Medscape.com.
According to InjectableSafety.org, treatment with botulinum type A relaxes the muscles that cause expression lines, thereby preventing wrinkles from forming while improving the appearance of existing wrinkles caused by facial expressions.
Xeomin, created by Merz Aesthetics, was previously approved by the FDA to treat cervical dystonia (abnormal neck pain and movements) and blepharospasm (abnormal, involuntary blinking or spasm of the eyelids), YourPlasticSurgeryGuide.com reports.
The approval of Xeomin for cosmetic use follows two separate clinical trials involving nearly 550 adults. In both studies, Xeomin injections significantly improved the appearance of glabellar lines 30 days after the first injection when compared with placebo.
"The nice thing is we'll have yet another injectable and we can figure out as time goes by, and as we use it with more patients, who is the best patient for which option," a New York-based dermatologist told AmericanHealthAndBeauty.com. "As a cosmetic dermatologist, one of the best things for me is to have more in my tool box, so that when a patient comes in I can tailor treatment to the patient's needs."
"Xeomin has a shelf-life of two to three years, not refrigerated," a Miami-based cosmetic dermatologist told Medscape.com. "That's a tremendous advantage for doctors. Those of us who inject a lot of neurotoxin, we need a lot of refrigerator space, and the shelf-lives are relatively short - anywhere from a few months to a year, perhaps."
The injectable is already being widely used in other countries, such as Germany, France, the U.K., Italy and Spain. Merz officials say Xeomin will be available nationwide in the spring of 2012.
Meanwhile, another botulinum toxin injectable, PurTox, is currently being evaluated by the FDA as well. It is expected to be available in the U.S. in late 2012.
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