On Wednesday the Food and Drug Administration approved a new injectable treatment for reducing the double-chin.
Although it is not a life-threatening condition, over 70 percent of Americans have complained of having a double chin which is listed as only an aesthetic condition, according to the Los Angeles Times.
The new FDA-approved substance is called deoxycholic acid and will be sold as Kybella which will be the first medicine the FDA has ever approved for “moderate-to-severe fat below the chin.” The medical term being submental fat.
Kythera Biopahrmaceuticals is the company taking on the production of the medicine. It will be available to dermatologists, plastic surgeons and facial plastic surgeons later this summer. All of the doctors taking on the treatment for use on patients will need to be trained in the proper administration of the injectable first.
As for the price of the treatment, Kythera is not releasing that list until June, right before the product will be marketed and launched and the physicians are being trained to administer it.
Kybella is a synthetic version of deoxycholic acid which is a natural protein created by the body to help absorb fat. The injectable will be administered to the tissue under the chin, destroying the cell membrane. In other words, Kybella will dissolve the fat tissues causing a double-chin.
The only concern the FDA wanted to address was clarifying that Kybella is only for use under the chin, not for other parts of the body that contain unwanted fat. The drug has not been tested or approved for use except for the tissue under the skin of the chin area.
Up to six single treatments could be necessary in order to obtain the desired result of a less prominent double-chin. But in testing, most patients were happy after just three to four sessions. And unlike past attempts of treatments to reduce fat under the chin, Kybella has been tested and proved to be a treatment not needing follow-up or re-treatment after the initial sessions.
Dr. Derek Jones is the lead investigator of the Kybella clinical trial. Also the founder of Skin Care and Laser Physicians of Beverly Hills, he called deoxycholic acid “an extremely well-studied medicine” whose safety has been established in over 20 studies.
The only known side effects of the treatment from Kybella are temporary swelling and tenderness around the site of injections and possible bruising and numbness.
Like This Post? … Then Like Our Page
“We know now how to prevent that,” he said, noting that the nerve disturbance resolved itself in all cases.
Jones also added that in the clinical trial, 79 percent of the patients receiving Kybella expressed satisfaction with the aesthetic results.
“We’re aiming for progress, not perfection,” he cautioned.