Allergan Receives FDA Clearance To Treat Area Below The Jawline With CoolSculpting®
DUBLIN, Oct. 4, 2018 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the CoolSculpting® treatment received FDA clearance to treat the submandibular area. In addition, the FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and submandibular areas. This recent clearance makes CoolSculpting® the first and only nonsurgical fat reduction treatment to contour the area below the jawline and improve the appearance of lax tissue in conjunction with submental fat treatments.
"The CoolSculpting® treatment is the clinically proven safe and effective, leader in nonsurgical fat reduction with 9 clearances and over 7 million treatments performed1," said David Nicholson, Chief Research and Development Officer at Allergan. "This new indication to treat the submandibular area underscores Allergan's dedication to research and innovation within the body contouring category."
The efficacy of the CoolSculpting® treatment in the area right below the jawline was proven in a 22-week clinical study, which demonstrated an average 33 percent reduction in fat layer thickness after two treatments.2 Additionally, an average 85 percent patient satisfaction rate was reported across three studies.3
"As a physician and CoolSculpting® provider, I applaud the company's ongoing investment in advancing the CoolSculpting® treatment," said Eric Bernstein, MD, MSE, Director for the Main Line Center for Laser Surgery in Ardmore, Pa. "The ability to treat the area below the jawline allows me to offer my patients even more opportunities for nonsurgical fat reduction."
References
1 Data on File Allergan, Inc.
2 Leal Silva, Hernandez, Vazquez, Leal Delgado, & Blanco, 2017
3 Bernstein & Bloom, 2017; Kilmer, Burns, & Zelickson, 2016; Leal Silva, Hernandez, Vazquez, Leal Delgado, & Blanco, 2017
About the CoolSculpting® Treatment
CoolSculpting® is a non-surgical, clinically proven treatment that selectively reduces unwanted fat using a patented cooling technology. Cleared by the FDA, CoolSculpting® works by gently cooling targeted fat cells in the body to induce a natural, controlled elimination of fat cells without affecting surrounding tissue, and the treated fat cells are gone for good. In 2018, CoolSculpting® was recognized for the fifth consecutive year by NewBeauty as a Choice Award winner. Millions of CoolSculpting treatments have been performed in more than 80 countries. CoolSculpting® is available through a network of CoolSculpting® Centers worldwide. Dermatologists, plastic surgeons and aesthetic specialists that offer CoolSculpting® can be found at www.coolsculpting.com.
In the U.S., the CoolSculpting® procedure is FDA-cleared for the treatment of visible fat bulges in the submental and submandibular areas, thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll) and upper arm. It is also FDA-cleared to affect the appearance of lax tissue with submental area treatments.
During the procedure you may experience sensations of pulling, tugging, mild pinching, intense cold, tingling, stinging, aching, and cramping at the treatment site. These sensations subside as the area becomes numb. Following the procedure, typical side effects include temporary redness, swelling, blanching, bruising, firmness, tingling, stinging, tenderness, cramping, aching, itching, or skin sensitivity, and sensation of fullness in the back of the throat after submental area treatment. Rare side effects may also occur. The CoolSculpting® procedure is not for everyone. You should not have the CoolSculpting® procedure if you suffer from cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria. The CoolSculpting® procedure is not a treatment for obesity. Please see full Important Safety Information for additional information.
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About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical leader. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry.
Allergan's success is powered by our global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
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SOURCE Allergan plc
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