SCOTTSDALE, Ariz., Oct 11, 2011 (GlobeNewswire via COMTEX) –Medicis /quotes/zigman/156404/quotes/nls/mrx MRX -0.08% today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement to expand the approved use of RESTYLANE(R) Injectable Gel, a hyaluronic acid dermal filler, to include lip augmentation. RESTYLANE was previously approved to treat moderate to severe facial wrinkles and folds, such as the lines from the nose to the corners of the mouth (nasolabial folds). the new label will now include an indication for submucosal implantation for lip augmentation in patients over the age of 21. the RESTYLANE package insert will be amended to include the new indication, along with results from the clinical trials for lip augmentation. the Company anticipates using this information in its training and promotional activities.
a photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=10827
“We are pleased with the FDA’s decision to expand the RESTYLANE label to include lip augmentation,” said Jonah Shacknai, Chairman and Chief Executive Officer of Medicis. “This marks another significant milestone for RESTYLANE, now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation. We were very encouraged by the compelling data from the robust pivotal clinical study, showing effectiveness for up to six months, with a clear majority of eligible subjects opting for retreatment at six months. We believe physicians and their patients will appreciate the unique gel particle structure of RESTYLANE and its ability to create fullness in the lips for up to six months.”
about the Pivotal Study1
This randomized, evaluator-blinded, no-treatment-as-a-control, multi-center study enrolled 180 patients to evaluate the safety and effectiveness of RESTYLANE for lip augmentation in both the upper and lower lip. Subjects randomized to RESTYLANE treatment at the beginning of the study were retreated at six months, and subjects randomized to no treatment received their first RESTYLANE treatment at six months. Safety was measured by adverse events reported throughout the study and patient diaries kept for two weeks after lip augmentation treatment. Additionally, Medicis designed nine lip safety assessments which were performed at various intervals throughout the seven-month study, including 72 hours after each treatment and again at two weeks after each treatment.
Medicis also designed an innovative, five-point measurement tool to evaluate lip augmentation effectiveness called the Medicis Lip Fullness Scale(TM) (Medicis Lip Scale) (patent pending), collaborating closely with FDA and clinicians during the scale development and validation process. Effectiveness was measured for both the upper and lower lip using the Medicis Lip Scale by a blinded live evaluator, an independent photo reviewer and the treating physician. Effectiveness was also measured for both the upper and lower lip using the Global Aesthetic Improvement Scale (GAIS) by the patient and the treating physician. Effectiveness was measured monthly for seven months throughout the study.
the study was conducted by 12 physicians. Independent photo evaluations were conducted by three independent physicians after the study was completed.
RESTYLANE was found to be well tolerated and highly effective for lip augmentation for up to six months, meeting both primary and secondary endpoints.
Results of all effectiveness endpoints in the upper lip, the lower lip or both lips combined were directionally consistent and highly statistically significant throughout six months as measured by all evaluators (blinded live evaluators, independent photo reviewers, treating physicians and patients), regardless of the tools utilized (Medicis Lip Scale or GAIS). Adverse events were primarily pain, swelling, tenderness, bruising and erythema; none were serious. An overwhelming majority of patients (80%) chose retreatment after six months due to the aesthetic results of RESTYLANE.
RESTYLANE is the most-studied aesthetic dermal filler in the world, and has been used in over 10 million treatments worldwide.2 Launched in the U.S. in January 2004 after approval by FDA on December 12, 2003, RESTYLANE was the first hyaluronic acid dermal filler approved in the U.S. Hyaluronic acid is a substance naturally present in the body. the hyaluronic acid in RESTYLANE closely resembles the body’s natural hyaluronic acid and is produced from a nonanimal source, making it free from animal protein, a quality which prevents disease transmission. Allergy pretesting is not necessary.
RESTYLANE has a unique gel particle structure designed for injection in the mid-to-deep dermis for structural support and lift, helping a patient look younger by smoothing away moderate to severe facial wrinkles and folds, such as the nasolabial folds. RESTYLANE’s water-loving nature attracts and binds water molecules to help maintain volume.
RESTYLANE was shown to have an overall duration of effectiveness lasting up to 18 months from baseline following one repeat treatment at 4.5 or 9 months in the nasolabial folds. RESTYLANE is injected into the tissue and will, in time, be resorbed by the body as the treatment results gradually wear off.
about the Market
according to the American Society for Aesthetic Plastic Surgery (ASAPS), Americans spent nearly $10.7 billion on cosmetic procedures in 2010. of that total, injectable procedures such as RESTYLANE represented $1.9 billion. ASAPS also recently reported that hyaluronic acid procedures were the second most popular nonsurgical cosmetic procedures in 2010, preceded only by botulinum toxin type a injections.3
the complete RESTYLANE family of products currently approved for use in the U.S. by FDA includes RESTYLANE, RESTYLANE-L(R), PERLANE(R) and PERLANE-L(R). these products can be used individually to add volume and fullness to the skin to correct moderate to severe facial wrinkles and folds, such as the lines from your nose to the corners of your mouth (nasolabial folds). RESTYLANE may also be used for lip enhancement in patients over 21 years. ask your doctor which is right for you.
RESTYLANE is patented until at least 2017 by U.S. Patent No. 5,827,937.
Important Safety Considerations for the RESTYLANE Family of Products
Products in the RESTYLANE family should not be used by people with previous bad allergies, particularly to microorganisms known as gram-positive bacteria, or by people with serious allergies to drugs that have previously required in-hospital treatment. these products should not be used by people with bleeding disorders. Products should not be injected anywhere except the skin, just under the skin (PERLANE and PERLANE-L only), or in the lips (RESTYLANE only). RESTYLANE-L and PERLANE-L should not be used by anyone with a known allergy to lidocaine.
use at the site of skin sores, pimples, rashes, hives, cysts or infection should be postponed until healing is complete. in these instances, product use could delay healing or make your skin problems worse. After treatment, you might have some swelling, redness, pain, bruising or tenderness. these are typically mild in severity and normally last less than 7 days in nasolabial folds and less than 14 days in lips. Swelling may be more likely in patients under 36 years, and bruising may be more likely in patients over 35 years. Rarely, the doctor may inject into a blood vessel, which can damage the skin. Although rare, red or swollen small bumps may occur. If you have had facial cold sores before, an injection can cause an outbreak. to avoid bruising and bleeding, you should not use the products if you have recently used drugs that thin your blood or prevent clotting. Products should not be used during pregnancy, when breastfeeding or in patients under 18 years for nasolabial folds.
Treatment volume should be limited to 6.0 mL in wrinkles and folds, such as nasolabial folds, and limited to 1.5 mL per lip (RESTYLANE only), as greater amounts significantly increase moderate and severe injection site reactions. the safety or effectiveness of treatment in areas other than nasolabial folds and lips (RESTYLANE only) has not been established in controlled clinical studies.
the RESTYLANE family of products is available only through a licensed practitioner. Complete product and safety information is available at www.RestylaneUSA.com .
Medicis is the leading independent specialty pharmaceutical company in the United States focusing primarily on the treatment of dermatological and aesthetic conditions. the Company is dedicated to helping patients attain a healthy and youthful appearance and self-image. Medicis has leading branded prescription products in a number of therapeutic and aesthetic categories. the Company’s products have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance.
the Company’s products include the brands DYSPORT(R) (abobotulinumtoxinA) 300 Units for Injection, PERLANE(R) Injectable Gel, PERLANE-L(R) Injectable Gel with 0.3% Lidocaine, RESTYLANE(R) Injectable Gel, RESTYLANE-L(R) Injectable Gel with 0.3% Lidocaine, LOPROX(R) (ciclopirox) Gel 0.77% and Shampoo 1%, SOLODYN(R) (minocycline HCl, USP) Extended Release Tablets, VANOS(R) (fluocinonide) Cream, 0.1%, ZIANA(R) (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel, AMMONUL(R) (sodium phenylacetate and sodium benzoate) Injection 10%/10%, BUPHENYL(R) (sodium phenylbutyrate) Tablets and Powder and the over-the-counter brand ESOTERICA(R).
for more information about Medicis, please visit the Company’s website at www.Medicis.com . Printed copies of the Company’s complete audited financial statements are available free of charge upon request.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. all statements included in this press release that address activities, events or developments that Medicis expects, believes or anticipates will or may occur in the future are forward-looking statements. these statements are based on certain assumptions made by Medicis based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. No assurances can be given, however, that these activities, events or developments will occur or that such results will be achieved. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Medicis. several of these risks are outlined in the Company’s most recent annual report on Form 10-K for the year ended December 31, 2010, and other documents we file with the Securities and Exchange Commission. Forward-looking statements represent the judgment of Medicis management as of the date of this release, and Medicis disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.
NOTE: Full prescribing information for any Medicis prescription product is available by contacting the Company or by visiting www.Medicis.com . all trademarks are the property of their respective owners.
the photo is also available via AP PhotoExpress.
1 Medicis Global Services Corporation. MA-1300-15 Clinical Study Report. November 2010. Data on file. Medicis Pharmaceutical Corporation.2 Includes Q-Med AB HA products not available in the U.S. the first product, RESTYLANE, was approved for sale outside the U.S. in 1996.3 American Society for Aesthetic Plastic Surgery, Cosmetic Surgery National Data Bank Statistics, 2010.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Medicis Pharmaceutical Corporation
CONTACT: Medicis Kara Stancell (media) (480) 291-5454 Sean Andrews (investors) (480) 291-5854
(C) Copyright 2010 GlobeNewswire, inc. all rights reserved.