Clinical Trials coming soon! FDA still working with the company so I guess the trials are TBA for now. Kythera was formed by a group of former Amgen employees. If approved by the FDA, off label use here looks very attractive, forget the jaw and let’s get down the real problem areas (grin). BD
Kythera Biopharmaceuticals, announced “clinically meaningful” positive results from two phase II studies of its lead product, ATX-101, for zapping small fat deposits under the chin.
Details were sparse. But the closely held company said the studies, involving 157 patients, showed the experimental drug was “safe and tolerable” and also demonstrated a statistically significant improvement over a placebo. Side effects seen in the studies included
temporary swelling of the injected area as well as mild post-injection pain followed by temporary numbness.
The tests were performed on fat deposits immediately beneath the chin and jaw line. If the drug were to obtain FDA approval it would also be possible for physicians to use it off-label in other parts of the body, such as the thighs and abdomen, where many people carry unwanted fat.
Kythera, based in Los Angeles, said it expects to enroll a “substantial” number of patients for its pivotal human tests, but declined to discuss specifics or timing. The firm said it has been discussing various aspects of the trial with the FDA
Health Blog : Injected Fat-Dissolver Shows Promise in Human Tests
At present the FDA are not working with any company for the injection, they have SAID that there has been no studies done by them. They have no evidence to support any of the claims and there is a very long way to go before they will even consider looking at the data.
ReplyDeleteThey also have tried banning many online retailers as the two drugs that are used in this has not been given any approval as been combined and to be safe in the long run.
Several people who have used this (illegally) have ended up regretting it as they have been permanently disfigured. One woman 5 years later is still scarred badly, it not only can cause you serious cosmetic harm but as no proper research has been done no-one can say what the side effects or the permanent damage could be.
please be careful check with the FDA and you yourself will see this is not classed as a safe injection on anyone.