ATX-101, a new drug being tested in the Bay Area, may be the first-of-its-kind to get rid of that unwanted fat without any surgery. Stephanie Chuang reports. Read the full story
From those so-called love handles to the double chin, there are frustrating areas on your body that hold the last bit of fat - and no matter how much you sweat and diet, they just won’t go away.
But a new drug being tested in the Bay Area may be the first-of-its-kind to get rid of that unwanted fat, specifically under the chin, without any surgery.
ATX-101 developed by Kythera Biopharmaceuticals is a fat-dissolving injectable that is wrapping up its third and final phase of testing by the Food and Drug Administration after eight years of research and development.
Patients at the University of California at San Francisco have taken part in those trials. Dr. Sarah Arron with UCSF’s dermatology department, said the drug would be the first fat-dissolving injectable approved by the FDA in the United States.
“Any drug that gets approved in the U.S. has to get through rigorous testing by the FDA,” Arron said. “This includes both safety testing and efficacy testing of whether it actually works.”
Kythera Biophamaceuticals said there’ve been 15 international clinical trials involving more than 2,500 patients or subjects. ATX was tested in 1,500 of them. So far, the negative side effects reported include bruising and pain. And some wonder if would-be patients would substitute healthy lifestyle choices for the easy out of the injectable.
ATX-101 is designed to reduce what’s known as "submental" chin fat, more commonly referred to as the double chin. The drug’s main active ingredient is sodium deoxycholate, the same ingredient used in many laundry detergents. That is what helps break down the fatty tissue to get the oil and grease stains out of clothes. Arron described sodium deoxycholate as a biosalt, the same kind of salt that intestines make to digest the fat that people consume.
“Some patients call it the ‘wattle,’ some patients say it’s the last five pounds, and really, it’s something that many women are troubled by,” Arron said. She said ATX-101 would essentially melt or dissolve the fat away. “The idea is that the compound breaks down the fat cell and then your own body gathers it and excretes it naturally.”
Arron also performs the only other FDA-approved instant fat-burning method: liposuction. The surgery involves doctors making incisions by the ears and sometimes under the chin, sticking a needle in and sucking the fat out. Liposuction, she said, is an invasive surgical procedure that may carry potential complications.
“Many women don’t want to go through the downtime of the surgical procedure, it can be a two-week or more recovery period,” Arron said. “And it can be really uncomfortable afterwards. There can be pain and bruising afterward. Then there are rarer risks like nerve damage or damaged muscles of the neck.”
Any other injectable out on the market that claims to burn or melt away fat through a non-invasive procedure has not undergone rigorous FDA safety tests, and therefore are not and have not been regulated.
“There have been many reports of similar drugs for melting fat and they’ve gone by names like mesotherapy or subcutaneous injectables,” Arron said. “We’ve heard horror stories of patients being injected at salons or spas by non-physicians who have wound up with paraffin lumps under their chin, needing surgery to remove or very bad allergic reactions.”
Lisa Richardson, dietician, personal trainer and owner of Fitness Clinic of Los Gatos, said the new drug sounds promising, but she is concerned about people trying to take shortcuts over the age-old advice of eating healthy and working out. Richardson said fat cells removed through procedures like liposuction would come back in another part of the body.
“It will come back somewhere else, so I worry sometimes will your cheeks get really big, would you gain fat around your Adam’s apple?” asked Richardson. “The fat will go somewhere if you’re geared to producing a certain amount of fat cells and you don’t change your lifestyle, you will still continue to put on fat.”
While the FDA clinical trials have focused on injecting in the chin area, Arron said it could potentially be used in other places. The catch? Doctors must tell their patients the drug was not studied for other parts other than the submental chin fat.
“I think our consumer demand for something like this is very high and that’s why people are taking those risks with non-approved medications,” Arron said. “So I’m really hoping for something safer and better for our patients in the future.”
ATX-101 is wrapping up the final phase of FDA testing in coming weeks. FDA approval of the drug could take at least a year, before the drug could hit the market.
Published at 8:08 AM PDT on May 7, 2013