DermNews: New Drug Shown to Reduce Double Chins Seeks FDA Approval

Want to get rid of your double chin without cutting calories or going under the knife? Here’s a name you’ll want to remember: ATX-101.

In September ATX-101, a new injectable that reduces submental fat (colloquially known as “double chins”), met the main and secondary goals of its clinical trials. Kythera, the biopharmaceutical company that manufactures ATX-101, announced plans to submit for approval by U.S. and Canadian regulatory authorities. If approved ATX-101 would be the first injectible on the market proven effective for treating double chins.

“Undesirable double chin is often undertreated by aesthetic physicians as there is no proven non-surgical option to effectively reduce submental fat,” Jean D. Carruthers, M.D., an investigator involved in the trial and Clinical Professor, Department of Ophthalmology, University of British Columbia, Vancouver, said in a press release. Dr. Carruthers, who is on the Kythera Advisory Group, pioneered the use of botox for cosmetic use.

The clinical trial involved over 1,000 people with moderate to severe submental fat. Some subjects received injections of ATX-101 while others received placebos. 46.6% of the subjects who received ATX-101 experienced a decrease in volume of their double chin. Only 5.4% of the placebo patients experienced the same degree of fat shrinkage.

Following treatments of ATX-101 recipients reported perceiving themselves as happier, less bothered, less self-conscious, less embarrassed, younger or less overweight. Patients also experienced adverse effects, such as swelling, pain, bruising, numbness and redness, but, according to Kythera, none were treatment-related.

“We look forward to discussing submission plans with U.S. and Canadian regulatory authorities in the near future,” said Frederick Beddingfield, III, M.D., Ph.D., Chief Medical Officer, KYTHERA Biopharmaceuticals, Inc.