FDA Close to Approving Shot to Eliminate Double Chins

Although the final decision from the Food and Drug Administration (FDA) is not expected to come down until sometime in May, approval of a drug that helps reduce or eliminate double chins has received a green light.

The Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA is recommending approval of deoxycholic acid or DCA, which is an injectable drug proven to reduce submental fat associated with double chins in adults. If final approval is granted, DCA will be the first medical treatment for excessive fat underneath the chin.

Deoxycholic acid works by destroying fat cell membranes at the site of injection. Structurally, DCA is identical to endogenous deoxycholic acid although according to FDA regulations, there is a new molecular entity.

In the two clinical trials conducted, results showed that injectable DCA was far superior when compared to placebo, not only for primary endpoints but secondary as well.

In 13.4% and 18.6% of people who participated in the trials, two-grade improvements were noted. Comparatively, for participants in the placebo groups only 0.1% and 3% respectively were confirmed. In addition, 70% and 66.5% of participants had one-grade improvements whereas just 18.6% and 22% saw change within the placebo groups.

Using magnetic resonance imaging (MRI), medical researchers were able to see 46% and 40.5% improvement for those injected with DCA compared to 5.2% and 5.3% in the placebo groups. According to Dr. Lynn Drake, committee chair and lecturer at Harvard Medical School, as well as top dermatologist with Massachusetts General Hospital, DCA offers a solution that until this time has not been available.

She stated that improvement in little things like the reduction or elimination of chin fat can bolster a person’s self-worth and self-esteem.

The two pivotal, phase three trials were sponsored by Kythera Biopharmaceuticals and consisted of 1,022 patients from throughout North America. Most of the participants were white females between 40 and 50 years of age. During the trials, participants were injected using a 1 centimeter grid over a four-week period. The maximum number of sessions was six and no more than 50 injections of DCA were administered to each individual.

Dr. Leo McCafferty, a well-known plastic surgeon, was pleased with the outcome of the trials, saying that it is becoming more and more important to find medical procedures that are noninvasive, have little or no risk, and allow quick recovery.