Liposculpting agent under investigation for small-volume submental fat

Key Points

Consumer demand is high for injectable fat-reduction agents
Kythera's product, ATX-101 (sodium deoxycholate) is making progress, but still a far leap from approval

Mr. Leonard

NATIONAL REPORT Consumer demand for an investigational pharmaceutical that reportedly reduces localized fat is one small step closer to being satisfied. The product, Kythera Biopharmaceuticals, Inc.'s ATX-101 (sodium deoxycholate) is, however, still a giant leap away from being labeled safe and effective or being available to the public.

Kythera recently announced that it is set to begin a second phase II clinical trial of ATX-101 for the reduction of submental fat. This clinical trial is the second in a series of phase II studies of ATX-101 for aesthetic applications, and is aimed at assessing the safety and effectiveness of ATX-101 as a 'liposculpting' agent.

The initiation of this second phase II trial delivers on Kythera's pledge to conduct rigorous scientific and clinical testing on all of its products, according to Keith Leonard, Kythera's President and CEO.

Dr. Hirsch

"It moves us one step closer to meeting consumer and physician demand for a safe, effective, well-studied and approved product for localized fat reduction," Mr. Leonard tells Cosmetic Surgery Times . The ultimate goal of the clinical testing program is registration of ATX-101 as an approved prescription drug in the U.S., Europe and Asia.

Few U.S. studies have been undertaken on injectable fat-reduction agents, notes Boston-based dermatologist Ranella Hirsch, M.D., president of the American Society of Cosmetic Dermatology & Aesthetic Surgery (ASCDAS).

Dr. Goldberg

"There is actually a large global body of data on the use of injectable techniques for fat dissolution, but markedly less so in the United States to this point," she says. "A number of products are unproven and poorly studied, unlike this one, where the company is pursuing rigorous clinical studies for approval of the product. If approved, it will be an exciting addition to the aesthetic armamentarium and will allow cosmetic surgeons a welcome treatment option for localized fat deposits."

David J. Goldberg, M.D., director of Skin Laser & Surgery Specialists of New York/New Jersey and clinical professor of dermatology at New York's Mount Sinai School of Medicine, agrees that there is significant marketplace demand for nonsurgical methods for removing fat. His practice's research center is one of the FDA sites for the Kythera ATX-101 study. "The drug is currently being studied for the nonsurgical improvement of the fat in lipomas," he says, "and it appears to have promise and viability as a fat-reduction therapy."

Dr. Schlessinger

Omaha, Neb., dermatologist Joel Schlessinger, M.D., was also an investigator in the initial phase II trial on ATX-101. He holds no stock in the company and does not serve as a consultant.

"There is a need for a product like this but only if it is safe and effective, and that is what these trials are hopefully going to tell us," says Dr. Schlessinger, immediate past president of the ASCDAS. "So far, we have submitted the data to the FDA and, if approved for further study in the United States, we will see if the product meets these criteria in areas such as submental fat." According to Dr. Schlessinger, there have been problems with products like this in the past, due mainly to lack of adequate studies.

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Liposculpting agent under investigation for small-volume submental fat reduction

Article-Liposculpting agent under investigation for small-volume submental fat reduction

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