Injected Fat-Dissolver Shows Promise in Human Tests - Kythera
Posted Jan 07 2009 5:10pm
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
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 itoff-labelin 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