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Allergan, Inc. Announces FDA Approval Of JUVEDERM R XC Dermal Filler Formulated With Lidocaine


Allergan, Inc. (NYSE:AGN) announced the U.S. Food and Drug Administration's (FDA) approval of JUVEDERM(R) XC, a new formulation of the currently FDA-approved JUVEDERM(R) dermal filler and the latest advancement1 in hyaluronic acid (HA) dermal fillers. Allergan's new JUVEDERM(R) formulation contains the local anesthetic lidocaine to provide patients with enhanced comfort during treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds (or "parentheses") that appear around the nose and mouth. JUVEDERM(R) is the first and only hyaluronic acid dermal filler approved by the FDA to last up to one year from initial treatment2 and number-one selling hyaluronic acid dermal filler.3
"As the global leader in medical aesthetics, Allergan is committed to providing the latest scientific advancements in facial aesthetic products to meet patients' demands and further optimize their experiences," said Robert Grant, Allergan's Corporate Vice President and President, Allergan Medical. "We lead innovation in the dermal filler category with the first and only smooth-consistency gel hyaluronic acid dermal filler approved by the FDA to last up to a year. Now we have added lidocaine to JUVĂ DERM(R) to provide the same smooth, long-lasting result, but with additional comfort for patients."
The JUVEDERM(R) XC formulation with 0.3% preservative-free lidocaine numbs the treatment area within seconds, potentially reducing the need for an additional anesthetic. JUVEDERM(R) XC provides the same smooth, long-lasting results as demonstrated with existing formulations of JUVEDERM(R), and now offers a more comfortable injection experience and potentially less time spent in the physician's office when compared to the non-lidocaine JUVEDERM(R) formulation.
"Patients want a smooth and natural-looking result from a dermal filler treatment, but as a physician I am also interested in managing my patient's discomfort during the injection. Before the introduction of JUVEDERM(R) XC it often took up to 30 minutes for an anesthetic block to take effect. In the clinical trial leading up to the FDA approval, patients reported they experienced less pain with JUVEDERM(R) XC, compared to their previous dermal filler treatment without lidocaine. So with the new formulation, patients can receive the same smooth results as demonstrated with JUVEDERM(R) but enjoy a more comfortable injection experience," said Charles Boyd, M.D., Boyd Cosmetic Surgical Institute and JUVEDERM(R) XC clinical investigator.
The FDA approval of JUVEDERM(R) XC was based on data from a multicenter, double-blind, randomized clinical trial. A total of 72 subjects were followed for two weeks after treatment with one of two JUVEDERM(R) formulations (JUVĂ DERM(R) XC with lidocaine or JUVEDERM(R) without lidocaine) in each nasolabial fold. In the clinical study (n=72), 93 percent of patients reported less pain when treated with the new formulation of JUVEDERM(R) compared to those treated with the non-lidocaine formulation of JUVEDERM(R).4 JUVEDERM(R) XC was found to be more effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the non-lidocaine formulation of JUVEDERM(R).
Following FDA's approval, the new formulation of JUVEDERM(R) with lidocaine is available for ordering nationwide. JUVEDERM(R) is a prescription-only treatment and should be administered by a qualified medical practitioner who has been trained in JUVEDERM(R) injection techniques.
Allergan encourages individuals interested in being treated with the JUVEDERM(R) family of products to visit www.Juvederm.com and access the JUVEDERM(R) Online Treatment Visualizer to upload a picture and help visualize how JUVEDERM(R) can potentially smooth away moderate to severe facial wrinkles and folds. This tool is for visualization and illustrative purposes only and is not a substitute for a consultation with a qualified medical practitioner.
JUVEDERM(R) Family of Products
Allergan's JUVEDERM(R) dermal filler product line includes JUVEDERM(R) Ultra and JUVEDERM(R) Ultra Plus in the United States, providing physicians with the flexibility to tailor each treatment to the particular needs of the patient. Both of these formulations will now be offered with lidocaine under the brand names, JUVEDERM(R) Ultra XC and JUVEDERM(R) Ultra Plus XC. JUVEDERM(R) XC is contraindicated in patients with a history of allergies to lidocaine.
A Brief Description of Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events for JUVEDERM(R) Injectable Gel
Indication: In the United States, JUVEDERM(R) injectable gel (including JUVEDERM(R) Ultra, JUVEDERM(R) Ultra Plus, JUVEDERM(R) Ultra XC, and JUVEDERM(R) Ultra Plus XC) is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Contraindications: JUVEDERM(R) injectable gel should not be used in patients who have severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies. JUVEDERM(R) should not be used in patients with a history of allergies to Gram-positive bacterial proteins. JUVEDERM(R) Ultra XC and JUVEDERM(R) Ultra Plus XC should not be used in patients with a history of allergies to lidocaine.
Warnings: JUVEDERM(R) injectable gel should not be injected into blood vessels. If there is an active inflammatory process or infection at specific injection sites, treatment should be deferred until the underlying process is controlled.
Precautions: The safety of JUVEDERM(R) for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established. The safety and effectiveness of JUVĂ DERM(R) injectable gel for the treatment of areas other than facial wrinkles and folds (such as lips) have not been established in controlled clinical studies. Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at injection site. Patients should inform their physician before treatment if they are using these types of substances. As with all skin-injection procedures, there is a risk of infection. JUVĂ DERM(R) should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body's immune response, as there may be an increased risk of infection. The safety of JUVĂ DERM(R) in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied. If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment with JUVĂ DERM(R) injectable gel, or if JUVĂ DERM(R) is administered before the skin has healed completely after such a procedure, there is a possible risk of an inflammatory reaction at the treatment site.
Adverse events: The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, and bruising. Most side effects are mild or moderate in nature, and their duration is short lasting (7 days or less).
CAUTION: Rx only.
Forward-Looking Statements
This press release contains "forward-looking statements," including the statements by Dr. Boyd and Mr. Grant, and other statements regarding the safety, effectiveness, adverse reactions, product availability, approval and market potential of JUVEDERM(R) injectable gel and JUVEDERM(R) injectable gel with lidocaine. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product formulation; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2008 Form 10-K and Allergan's Form 10-Q for the quarter ended September 30, 2009.
About Allergan, Inc.
Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs approximately 8,500 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.
© 2010 Allergan, Inc. Irvine, CA 92612. (R) and (TM) Marks owned by Allergan, Inc. JUVEDERM(R) is a mark owned by Allergan Industries SAS
References
(1) Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of JuvĂ derm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10.
(2) Pinsky MA, Thomas JA, Murphy DK, Walker PS; for the JuvĂ derm vs Zyplast Nasolabial Fold Study Group. JuvĂ derm Injectable gel: A multicenter, double-blind, randomized study of safety and effectiveness. Aesthetic Surg J. 2008; 28(1):17-23.
(3) Guidepoint Global Tracking for US Dermal Fillers, January - October 2009
(4) Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A multi-center, double-blind, randomized controlled study of the safety and effectiveness of JuvĂ derm injectable gel with and without lidocaine. J Cosmet Dermatol. 2009 Sep;8(3):205-10.
Source: Allergan, Inc

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