IncobotulinumtoxinA Gets FDA Okay for Frown Lines

Megan Brooks

July 21, 2011

July 21, 2011 — The US Food and Drug Administration (FDA) has approved incobotulinumtoxinA (Xeomin, Merz Aesthetics) for a temporary improvement in the appearance of moderate to severe glabellar (frown) lines, the manufacturer announced today.

The approval of incobotulinumtoxinA is based on the results of 2 multicenter US clinical trials involving 547 healthy adults. In both studies, incobotulinumtoxinA significantly improved the appearance of glabellar lines 30 days after the first injection when compared with placebo, the company said.

Headache was the most common adverse reaction seen in the studies (incidence, ≥2% of patients and greater than placebo).

"Xeomin is a promising new option for both patients and physicians and we are encouraged by the response rates seen in the phase III clinical trials," said Derek H. Jones, MD, an investigator for the US studies, clinical associate professor of medicine at the University of California–Los Angeles, and director of Skin Care and Laser Physicians in Beverly Hills, California, in a company press release.

IncobotulinumtoxinA is already approved for a temporary improvement in the appearance of glabellar lines in 14 countries in the European Union, including Germany, the United Kingdom, France, Italy, and Spain, under the brand name Bocouture.

It was approved by the FDA in July 2010 for the treatment of cervical dystonia and blepharospasm.

No Need to Refrigerate

Oscar Hevia, MD, from Hevia Cosmetic Dermatology in Miami, Florida, has used incobotulinumtoxinA both therapeutically and aesthetically. He told Medscape Medical News that any patient who would benefit from onabotulinumtoxinA (Botox, Allergan) or abobotulinumtoxinA (Dysport, Medicis) would benefit from incobotulinumtoxinA. "It will be used in the same manner as the other 2 [drugs] have been used for cosmetic purposes."

What is novel about incobotulinumtoxinA, he said, is that it is free from complexing proteins and does not need refrigeration before reconstitution.

"The big advantage to Xeomin, I think, is in its storage and shelf-life," Dr. Hevia said.

Because it is the "naked" protein (unlike onabotulinumtoxinA and abobotulinumtoxinA), "Xeomin has a shelf-life of 2 to 3 years, not refrigerated. 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," said Dr. Hevia, who was not involved in the clinical trials of incobotulinumtoxinA.

The company emphasizes in a statement that potency units of incobotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products. "Units of biological activity of Xeomin cannot be compared to or converted into units of any other botulinum toxin products."

IncobotulinumtoxinA is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation, as well as in the presence of infection at the proposed injection site or sites. Hypersensitivity reactions have been reported with botulinum toxin products (eg, anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea).

Patients with neuromuscular disorders may be at increased risk for clinically significant effects, including severe dysphagia and respiratory compromise from typical doses of the neurotoxin, the company notes.

They further note that individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin.

Concomitant treatment of incobotulinumtoxinA and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (eg, tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of the drug may be potentiated, the company says.

There are no adequate and well-controlled studies in pregnant women. IncobotulinumtoxinA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, the company states.

IncobotulinumtoxinA will be available nationwide in the spring of 2012, the company said.

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