FDA panel recommends approval of injections to get rid of double chin

It sounds almost too good to be true – injections of a drug that melt fat away. Could it mean an end to the dreaded selfie double-chin?

FDA panel recommends injection for double chin


Dermatologists seem to think so, and so does a panel advising the Food and Drug Administration. They voted unanimously this week to approve a tiny biotech company’s drug for a very specific and targeted use of its fat-busting drug—to get rid of double chins.

Kythera has been working on the drug, simply known as ATX-101, for years. Now, clinical trials have shown it’s safe, and makes people happier with their double chins.

If approved, it could be offered as an alternative to surgery, says Dr. Susan Weinkle, a dermatologist in Bradenton, Florida, who helped test the drug in patients. The FDA usually follows the advice of its committees, although not always.

“There no other FDA-approved drug like it at all. There is nothing on the market,” Weinkle told NBC News.

ATX-101 is a specially formulated version of a natural compound found in the body called deoxycholic acid. It’s produced as part of the digestive process and its job is to break down fat.

An FDA advisory panel has recommended approval of a new, fat-melting drug for double chins
An FDA advisory panel has recommended approval of a new, fat-melting drug for double chinsKythera Biopharmaceuticals

“It causes fat cells to rupture,” Weinkle said. “When you are born you have a certain number of fat cells. During life, these fat cells can be either skinnier or fatter. When you cause a fat cell to rupture, that cell is gone forever.”

California-based Kythera (pronounced KEE-ther-ah) hopes to use the drug to position itself as a medical “aesthetics” company – think cosmetic procedures akin to the widespread use of Botox. The company’s name comes from one of two Greek islands that claimed to be the birthplace of Aphrodite, Greek goddess of love and beauty.

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It’s carefully sought approval for ATX-101 for a very limited condition.

Medically, it’s called submental fat. Most people know it as a double chin, and Weinkle says the treatment involves a series of injections one month apart. They’d be done in the doctor’s office.

It’s not painless—most patients reported bruising, pain, numbness and swelling. A few reported scarier problems such as trouble swallowing, although it didn’t last long. Surgery often causes more serious side-effects.

And it’s definitely not for everyone, cautions Dr. Michael Edwards, president of the Society for Aesthetic Plastic Surgery.

“My biggest concern is once it is approved, people will start to use it for other areas of the face or for larger volumes (of fat) in other areas,” Edwards told NBC News.

Weinkle says it takes some skill and training to perform the injections properly. Patients are going to want a very even reduction of fat, there are delicate nerves in the area to be avoided, and the injections must go to a certain depth. “You have to understand the anatomy of the area,” she said.

But once a drug is approved by the FDA and on the market, any physician may prescribe it as he or she wishes. FDA does not consider how doctors may use a drug in their practices. That raises the question of spot reduction clinics.

Edwards worries patients will flock to untrained practitioners who may try to dilute the drug to use it on a larger area—something that could lead to lumpy results at best, and perhaps complications. He stresses that people should only seek treatments from board certified experts who are trained to do the procedure in question.

“If it were my face, or my wife’s face, or my mother’s face I would want somebody who knows what they are doing,” Edwards said.

The American Society for Aesthetic Plastic Surgery plans to release a report Wednesday showing a 42 percent increase over the past year in nonsurgical fat reduction treatments. The most popular surgical procedure last year? Liposuction with 342,494 procedures performed. It costs, on average, around $3,000.

“People go through all sorts of shenanigans to get their neck to look the way they want.”

Many of those are for the double chin.

“People go through all sorts of shenanigans to get their neck to look the way they want,” Edwards said.

Nonsurgical alternatives include CoolSculpting, Vaser Shape and Liposonix, with more than 135,000 of these procedures done last year. Edwards said they work somewhat well, in carefully chosen patients, but none produce dramatic results.

The same would be true for ATX-101.

“And a lot depends on the patient. It’s not a weight loss treatment,” Weinkle stresses. “This is not for decreasing your overall BMI (body mass index),” she said.

Some patients with very fat necks might end up with wattles of loose skin, and patients whose skin isn’t naturally elastic might also end up with “turkey neck”.

But the process itself appears to be safe, at least when the injection is used to remove very small amounts of fat. The body seems to absorb and excrete the busted-up fat cells, the studies show.

“I personally think it is going to be very exciting,” says Weinkle, who plans to offer the procedure in her office. The company declined any comment and hasn’t released any information about potential pricing.

“I can’t wait to inject myself. Which of us doesn’t have a little bit of fat under our chin?”

This article was originally published Mar. 10, 2015 at 5:29 p.m. ET.