ATX-101 will create a new market in facial aesthetics if approved

November 8, 2014

If approved for use, sodium deoxycholate (ATX-101) will create a new market in terms of how we think about fat and facial aesthetics, Adam M. Rotunda, M.D., FACMS, a diplomate with the American Board of Dermatology told Dermatology Times at the 2014 Annual Meeting of the American Society for Dermatologic Surgery this weekend.

The hoopla about a potential new injectable treatment for reduction of neck fat - sodium deoxycholate (ATX-101) - is well deserved, says a speaker at the 2014 Annual Meeting of the American Society for Dermatologic Surgery.

READ: More coverage of the 2014 ASDS Annual Meeting

“If approved for use, this medication will create a new market in terms of how we think about fat and facial aesthetics,” says Adam M. Rotunda, M.D., FACMS, a diplomate with the American Board of Dermatology in an interview with Dermatology Times. “As dermatologists, we've been accustomed to addressing patient aesthetic concerns primarily from the chin up. However, the neck or submental region is critical in framing the lower half of the face and creating our profile. Changes in the neck as we age or gain weight can have profound effects on our self esteem or self perception,” Dr. Rotunda says.

Via ATX-101, he says,”we would be able to offer patients an injectable/minimally invasive/non-surgical treatment to reduce small pockets of fat. Furthermore, improving the appearance of the neck with ATX-101 has been shown in Kythera's clinical trials to make patients happier, less embarrassed, younger and less overweight.”

Dr. Rotunda, who’s a fellow with American College of Mohs Surgery and assistant clinical professor of dermatology at UCLA’s David Geffen School of Medicine and the University of California, Irvine, says the FDA is expected to rule on the status of ATX-101 by May 2015.

In terms of reducing fat by injectable, “to date, there are no commercially available injectable treatments that have been cleared by the FDA for use in patients,” Dr. Rotunda says.  “Therefore, the compounds used - there's a history of their use dating back 20 years - had questionable and unregulated purity and dosing, and they were not rigorously evaluated in terms of safety and efficacy.”

As for side effects, Dr. Rotunda says they’re “to be expected, like most injectable aesthetics currently available. Swelling, bruising and numbness were found to be transient and mild to moderate. Injection site pain was similarly found to be transient and mild to moderate.”

But, he says, there are indications that lidocaine, ice and NSAID painkillers can significantly reduce pain. “Interestingly, all of the local adverse effects decreased in intensity after each treatment session," he says. "It's as though a 'virgin' neck will have a slightly more intense experience in terms of adverse events than a neck that's been previously treated with sodium deoxycholate.”

There are some cautions. Patients with very lax skin should not undergo the treatment, Dr. Rotunda says. And multiple treatments may be required. “Although patients may experience an improvement about a month after one treatment, the product's maximum efficacy is seen in upwards of six treatments spaced month. Although I do not believe in the real world most patients will require nor desire that many.”

In the big picture, Dr. Rotunda says, “many of my colleagues and I are very excited about this new potential new treatment. We've all been waiting for something new in injectables that's not a toxin or filler.”