Kybella: FDA Approves Non-surgical Drug for Double Chin

In a 2014 survey, about 68% of those asked by the American Society for Dermatologic Surgery said they are bothered by submental fullness... welcome Kybella

Submental fullness (double chin: subcutaneous fat that makes a person look older and heavier) has a new FDA approved treatment that gives medical spas who are not performing tumescent liposuction another newly approved treatment. (Liposuction is the current standard to remove submental fullness.) Good news for cosmetic physicians in the US who need FDA approval.

Kybella, (ATX-101 accordig to the Kythera website) is a patented formulation of deoxycholic acid. It is a less-invasive, non-surgical option treatment for submental fullness. It's manufactured by Kythera Biopharmaceuticals in California.

Kybella contours the area under the chin by destroying fat cells when it is injected into the adipose tissue or subcutaneous fat. Injections into the fat are done through a series of treatments, no less than one month apart. A natural healing and elimination process should follow.

The drug has been developed for more than 9 years. More than 2,600 patients were involved and 20 clinical studies were conducted. Noted side effects may include nerve injuries that may lead to a lopsided smile or facial weakness, bruising, redness, swelling, and pain.

The approval by the FDA of Kybella does not carry with it the approval of its use for fats located in other parts of the body.

In a statement made by the deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, Dr. Amy Egan mentioned that the drug is only approved for treatment of fat below the chin and it is not known if Kybella is safe or effective for treatment outside this area.

Download: Product Info & Final Labeling PDF - Indications, Dosage, and Injection Technique Information.