FDA gives new injectable a thumbs up

September 12, 2011

FDA gives new injection a thumbs up
FDA gives new injection a thumbs up

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.

Xeomin, which will be available under the brand name Bocouture, is derived from botulinum toxin type A, which is the same ingredient in Botox and Dysport.

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."

Experts say that the difference between Xeomin and Botox and Dysport is that it does not require refrigeration prior to reconstitution.

"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. 


The mission of the American Society for Aesthetic Plastic Surgery (ASAPS) includes medical education, public education and patient advocacy. Plastic Surgery News Briefs are summaries of current stories found through various news and magazine outlets that relate to or mention plastic surgery and cosmetic procedures. The views expressed in these news articles do not necessarily reflect the opinions of ASAPS, but are merely published as an educational service to our members and the general public. For additional information on these subjects and other plastic surgery related topics, please go to www.surgery.org

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The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body.  ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.

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