Woman with double chin
An injectable drug that reduces double chin or submental fat was unanimously recommended for approval by the Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration.
The "Deoxycholic Acid" (DCA) injection is "proposed for the improvement in the appearance of moderate-to-severe convexity or fullness associated with submental fat in adults." If it does secure final FDA approval, deoxycholic acid will be the first medical treatment for excess chin fat.
DCA destroys fat cell membranes at the injection site, said MedPage Today. It's structurally identical to endogenous deoxycholic acid but is a new molecular entity as far as FDA regulation is concerned.
Results in the two trials showed DCA injections were superior to placebo for both the primary and secondary endpoints.
Two-grade improvements were seen in 13.4 percent and 18.6 percent of participants receiving the active drug in the two studies, versus 0.1 percent and 3 percent of those in the placebo groups. Another 70 percent and 66.5 percent of subjects showed one-grade improvements, compared with 18.6 percent and 22.2 percent in the placebo groups.
The magnetic resonance imaging (MRI) scans showed 46 percent and 40.5 percent improvement in active-treatment groups compared with 5.2 percent and 5.3 percent improvements with placebo.
Committee chair Dr. Lynn Drake, a lecturer at Harvard Medical School and a dermatologist at Massachusetts General Hospital in Boston, said DCA answers an unmet need.
"We sometimes underestimate self-esteem and self-worth and how important these little things are and yet they're really important to patients," she said.
Sponsor Kythera Biopharmaceuticals conducted two pivotal phase three trials identicl in design and involving 1,022 patients in the U.S. and Canada. The majority of subjects were white, female and middle-aged.
Participants received injections "spaced on a 1 cm grid" every 4 weeks, with a maximum of six sessions and no more than 50 injections total, said briefing documents.
