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-- WITH PHOTO -- TO NATIONAL EDITORS:
Injectable Drug Offers Promises As A Nonsurgical Alternative To
Reducing Fat Under The Chin
SAN FRANCISCO, April 26, 2014 /PRNewswire-USNewswire/ -- Skin laxity
and fat buildup under the chin is a common concern among facial
aesthetic patients. Although surgery has long been the mainstay for
reducing fat in this area, which is also known as the submental
region, new research being presented at the Annual Meeting of the
American Society for Aesthetic Plastic Surgery (ASAPS) being held
April 24-29, 2014 in San Francisco, CA, shows the potential of a novel
injectable drug for submental fat reduction. Steven H. Dayan, MD who
practices in Chicago, IL, will present the latest data from clinical
trials of a new, investigational injectable drug, ATX-101, during
"ATX-101, A Submental Contouring Injectable Drug for the Reduction of
Submental Fat" on Saturday, April 26th.
"An unfavorable profile can make people look older and heavier,
negatively affect self-esteem, and cannot usually be significantly
altered by diet or exercise," said Dr. Dayan. "We are excited to
present trial results on this potential first-in-class submental
contouring injectable, which, if approved, could offer physicians and
their patients a non-surgical option to eliminate fat under the chin,
resulting in a thinner and more contoured profile and jawline."
Dr. Dayan is presenting the first disclosure of a pooled analysis of
two positive ATX-101 Phase III trials (REFINE-1 and REFINE-2)
evaluating the reduction of submental fat. Results of the pooled
analysis, conducted by KYTHERA Biopharmaceuticals, found that:
-- 68.2 percent of ATX-101 (2 mg/cm2) subjects demonstrated a
simultaneous improvement of at least one grade from baseline on
clinician and patient reported rating scales vs. 20.5 percent in
placebo (p<0.001).
-- After two treatments, 52.2 percent of subjects achieved at least a
one grade change from baseline in the clinician submental fat ratings,
and 71.5 percent after four treatments.
-- Response to ATX-101 was consistent across demographic and baseline
subgroups with approximately 80 percent of subjects treated with
ATX-101 demonstrating at least a one grade improvement in the
clinician submental fat ratings regardless of age, gender, race, BMI,
Fitzpatrick Skin Type and baseline severity.
-- Those treated with ATX-101 reported significant improvement in the
visual and emotional impact of chin fat, including appearing thinner
and more youthful, compared with those treated with placebo (p<0.001).
"Eliminating fat in the submental region not only plays a critical
role in helping restore overall facial balance and harmony, but can
also lead to vast improvements in self-perception as well as the first
impression projected," said Dr. Dayan. "We are looking forward to
sharing our findings, which show how a noninvasive injection might
offer patients the treatment option they've been desiring."
The pooled analysis also found that 80.9 percent of ATX-101
treatment-emergent adverse events were mild and 1.4 percent of ATX-101
subjects discontinued the studies due to adverse events. The most
common adverse events observed in the clinical trials included
temporary injection site events of pain, swelling, bruising and
numbness. The incidence and severity of pain and swelling declined
after the first treatment session.
ATX-101 is a proprietary formulation of a purified synthetic version
of a naturally occurring molecule (deoxycholic acid) that aids in the
breakdown of dietary fat. It is currently in late stage clinical
trials for the reduction of submental fat, which commonly presents as
a double chin. When injected into subcutaneous fat, ATX-101 contours
the area under the chin by destroying fat cells while leaving
surrounding tissue largely unaffected. It has been evaluated in
double-blind, randomized, placebo-controlled clinical trials being
conducted in the US and Canada with over 2,500 participants who have
moderate-to-severe submental fat. Detailed data from a pooled analysis
will be revealed during Saturday's presentation.
Title: ATX-101, A Submental Contouring Injectable Drug for the
Reduction of Submental Fat: A Pooled Analysis of Two Pivotal Phase 3
(REFINE-1 and REFINE-2) Multicenter, Double-Blind, Randomized,
Placebo-Controlled Trials
Date: Saturday, April 26th, 4:38 p.m. - 5:00 p.m.
Presenting Author: Steven H. Dayan, MD
Additional Authors: Derek H. Jones, MD, Jean Carruthers, MD, FRCS(c),
Shannon Humphrey, MD, Fredric S. Brandt, MD, Patricia Walker, MD,
Ph.D., Daniel Lee, MS, Paul F. Lizzul, MD, Ph.D., Frederick C.
Beddingfield III, MD, Ph.D.
CONTACT THE ASAPS COMMUNICATIONS STAFF TO SCHEDULE INTERVIEWS.
About ASAPS The American Society for Aesthetic Plastic Surgery (ASAPS)
is recognized as the world's leading organization devoted entirely to
aesthetic plastic surgery and cosmetic medicine of the face and
body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active
Members are certified by the American Board of Plastic Surgery
(USA) or by the Royal College of Physicians and Surgeons of Canada and
have extensive training in the complete spectrum of surgical and
non-surgical aesthetic procedures. International Active Members are
certified by equivalent boards of their respective countries. All
members worldwide adhere to a strict Code of Ethics and must meet
stringent membership requirements.
Website: www.surgery.org Follow ASAPS on
Twitter: www.twitter.com/ASAPS Become a fan of ASAPS on
Facebook: www.facebook.com/AestheticSociety Locate a plastic surgeon
in your area: http://www.smartbeautyguide.com/select-surgeon
Logo - http://photos.prnewswire.com/prnh/20140226/DC72077LOGO
SOURCE American Society for Aesthetic Plastic Surgery
-0- 04/26/2014
/CONTACT: Leigh Hope Fountain or Gloria Gasaatura: (562) 799-2356, leigh@surgery.org or gloria@surgery.org
/Photo: http://photos.prnewswire.com/prnh/20140226/DC72077LOGO
/Web Site: http://www.surgery.org
CO: American Society for Aesthetic Plastic Surgery
ST: California
IN: CPC MTC
SU: TRI
PRN
-- DC10582 --
0000 04/26/2014 18:00:00 EDT http://www.prnewswire.com
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