TORONTO, April 17, 2012 /CNW/ - Merz Pharma Canada Ltd. today announced that XEOMIN® COSMETIC has been approved by Health Canada for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows, in adult patients.
"The approval of XEOMIN COSMETIC in Canada adds a new treatment option for physicians and their patients across Canada," said Glenn Block, President and GM, Merz Pharma Canada Ltd. "XEOMIN has been approved for therapeutic indications in Canada since 2009, and with the approval of XEOMIN COSMETIC we now look forward to joining the 21 countries worldwide where it is used and approved for aesthetic use."
The approval of XEOMIN COSMETIC by Health Canada is based on the results of two pivotal clinical trials involving 547 healthy adult patients. In both studies, XEOMIN Cosmetic significantly improved the appearance of glabellar lines 30 days following the first injection when compared to placebo. XEOMIN and XEOMIN COSMETIC are the only botulinum toxin products currently approved in Canada that do not require refrigeration prior to reconstitution.
"I am encouraged by the patient response rates seen in the clinical trials for XEOMIN COSMETIC," said Vince Bertucci, MD, FRCPC, Medical Director of Bertucci MedSpa in Woodbridge, Ontario and Co-Director of the Cosmetic Dermatology and Laser Fellowship at the University of Toronto. "XEOMIN provides patients and physicians with a new option for the treatment of frown lines between the eyebrows."
XEOMIN is approved for the temporary improvement in the appearance of glabellar lines in the United States and in 14 countries in the European Union (EU), including Germany, the United Kingdom, France, Italy and Spain, under the brand name BOCOUTURE®.
XEOMIN COSMETIC will be available nationwide to physicians by summer.
About Glabellar Lines
When a person squints or frowns, the muscles between the eyebrows contract, causing the skin to furrow and fold. Over time, as skin loses elasticity, these repeated contractions can cause persistent frown lines, or the two lines in the shape of "11" between the eyebrows.
How XEOMIN COSMETIC works
XEOMIN COSMETIC is used in adults for the temporary improvement in the appearance of moderate to severe frown lines. XEOMIN COSMETIC is a medicine that relaxes the muscles. The medicinal ingredient in XEOMIN COSMETIC is Clostridium Botulinum Neurotoxin Type A complex, free from complexing proteins. The important nonmedical ingredients include albumin (human) and sucrose (sugar). XEOMIN COSMETIC comes in a white powder for solution for injection.
XEOMIN COSMETIC should not be used in patients who: are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of XEOMIN COSMETIC; have an infection present at the injection site; suffer from generalized disorders of muscle activity (e.g., myasthenia gravis, Eaton Lambert-Syndrome); or are pregnant or breast-feeding. Before use of XEOMIN COSMETIC, talk to your doctor or pharmacist. The advisability of use should be specifically discussed whenever a patient: suffers from any type of bleeding disorder; receives substances that prevent the blood from clotting (anticoagulant therapy); suffers from pronounced weakness or decreased muscle volume in the muscle where the injection will be received; suffers from a disease called amyotrophic lateral sclerosis (this disease leads to a wasting of muscle tissue); suffers from any disease that disturbs the interaction between nerves and skeletal muscles (peripheral neuromuscular dysfunction); has swallowing difficulties; has problems with injections of Botulinum toxin type A in the past; or is due to have surgery. Patients should tell the doctor if they are taking other medicines, including any bought at a pharmacy, supermarket or health food shop. Patients should seek immediate medical attention if swallowing, speech or respiratory problems arise (difficulty in swallowing food, ranging from very mild to sever, can persist for 2-3 weeks after injection or longer). Patients that experience drooping eyelids that interfere with vision, blurred vision or muscle weakness should avoid engaging in potentially hazardous activities such as driving until the adjustment by the patient to the changes or the issues have resolved.
About Merz (www.merzcanada.com)
Merz Pharma Canada Ltd., a wholly owned subsidiary of the Merz Group of Companies, was established in 2009 to expand Merz franchises in the Canadian Marketplace.
Merz Pharmaceuticals GmbH
Merz Pharmaceuticals, a member of the Merz Pharma Group of companies, is an innovative and international healthcare company specializing in the research, development and marketing of pharmaceuticals for the treatment of neurological and psychiatric diseases. Merz is a leader in the field of neurology. The company also focuses on the development of innovative therapies within the therapeutic areas of hepatology, metabolic disease and dermatology.
*XEOMIN COSMETIC is a trademark of Merz Pharmaceuticals GmbH, used under license.
The full product monograph, prepared for health professionals, can be found by contacting Merz Pharma Canada at: 1-866-815-8715.
This release was prepared by Merz Pharmaceuticals GmbH
SOURCE Merz Pharma Canada Ltd.
For further information:
Lauren Brunt, Medical Dynamics, +1-212-537-9495