CHADDS FORD, Pa., June 19 /PRNewswire/ -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. , today announced the commercial availability of Synera(TM) (lidocaine 70mg and tetracaine 70mg), a topical anesthetic patch. Synera(TM) is the first self-contained topical patch for prevention of pain associated with superficial venous access and superficial dermatological procedures in patients three years of age and older. Effective immediately, Endo will begin marketing the Synera(TM) patch in the institutional setting through its existing 70-person hospital sales force.
“We believe Synera(TM) offers patients and caregivers greater utility and convenience over currently available treatments for those who may experience pain with needle sticks,” said Peter A. Lankau, president and chief executive officer. “Synera(TM) has a two-step, peel and stick application, with a familiar, Band-Aid(R)-like appearance, and provides local dermal anesthesia. The recommended application time for the Synera(TM) patch is only 20 to 30 minutes. As a market leader in pain management, Endo is pleased to offer this exciting and innovative therapy to healthcare professionals for their adult and pediatric patients.”
The Synera(TM) patch addresses an important issue in the area of topical pain management, particularly in the pediatric population. According to published data, children under the age of 15 are hospitalized for an estimated 11.5 million days annually. Hospitalized children are routinely subjected to multiple superficial venous access procedures such as IV infusions, and blood draws.
In a joint statement issued in 2001, the American Academy of Pediatrics and the American Pain Society acknowledged that a substantial number of children are under-treated for their pain, and underscored the responsibility of physicians to “ensure humane and competent treatment of pain and suffering.”
“Pain caused by superficial venous access procedures -- such as IV infusions and blood draws -- can and should be anticipated and prevented,” said Susan T. Verghese, M.D., a pediatric anesthesiologist and director of cardiac anesthesia at Children’s National Medical Center, and professor, departments of anesthesiology and pediatrics at the George Washington University Medical Center in Washington, D.C.
“Synera(TM) is an exciting addition to what is currently available to treat superficial venous access pain in our pediatric population.”
About Synera(TM) (lidocaine 70mg and tetracaine 70mg)
The Synera(TM) patch is indicated for local dermal analgesia and consists of a thin, uniform, local anesthetic formulation with an integrated, oxygen- activated heating component that is intended to enhance the delivery of the local anesthetic. The drug formulation is an eutectic mixture of lidocaine 70 mg and tetracaine 70 mg.
Important Safety Information about Synera(TM)
Synera(TM) is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions. Synera(TM) is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, hypersensitivity to paraaminobenzoic acid (PABA), or sensitivity to any other component of the product. Synera(TM) should not be used for a longer duration than recommended.
The simultaneous or sequential application of multiple Synera(TM) patches is not recommended. Contact with the eyes should be avoided with Synera(TM). During or immediately after treatment with Synera(TM), the skin at the site of treatment may develop erythema, blanching, edema, or abnormal sensation. In clinical studies, the most common local reactions were erythema (71%), blanching (12%) and edema (12%). These reactions were generally mild, resolving spontaneously after treatment.
For full prescribing information, please visit http://www.synera.com .
About Endo
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo Pharmaceuticals is a fully integrated specialty pharmaceutical company with market leadership in pain management products. The company researches, develops, produces and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at http://www.endo.com .
Forward-Looking Statements
This press release contains forward-looking statements, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on management’s beliefs and assumptions, current expectations, estimates and projections. Statements that are not historical facts, including statements which are preceded by, followed by, or that include, the words “believes,” “anticipates,” “plans,” “expects” or similar expressions and statements are forward-looking statements. Endo’s estimated or anticipated future results, product performance or other non- historical facts are forward-looking and reflect Endo’s current perspective on existing trends and information. Many of the factors that will determine the Company’s future results are beyond the ability of the Company to control or predict. These statements are subject to risks and uncertainties and, therefore, actual results may differ materially from those expressed or implied by these forward-looking statements. The reader should not rely on any forward-looking statement. The Company undertakes no obligation to update any forward-looking statements whether as a result of new information, future events or otherwise. Several important factors, in addition to the specific factors discussed in connection with these forward-looking statements individually, could affect the future results of Endo and could cause those results to differ materially from those expressed in the forward-looking statements contained in this press release. Important factors that may affect future results include, but are not limited to: market acceptance of the Company’s products and the impact of competitive products and pricing; dependence on sole source suppliers; the success of the Company’s product development activities and the timeliness with which regulatory authorizations and product launches may be achieved; successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions; the availability on commercially reasonable terms of raw materials and other third party manufactured products; exposure to product liability and other lawsuits and contingencies; dependence on third party suppliers, distributors and collaboration partners; the ability to timely and cost effectively integrate acquisitions; uncertainty associated with pre- clinical studies and clinical trials and regulatory approval; uncertainty of market acceptance of new products; the difficulty of predicting FDA approvals; risks with respect to technology and product development; the effect of competing products and prices; uncertainties regarding intellectual property protection; uncertainties as to the outcome of litigation; changes in operating results; impact of competitive products and pricing; product development; changes in laws and regulations; customer demand; possible future litigation; availability of future financing and reimbursement policies of government and private health insurers and others; and other risks and uncertainties detailed in Endo’s filings with the Securities and Exchange Commission, including its Registration Statement on Form S-3 filed with the SEC on March 21, 2006. Readers should evaluate any statement in light of these important factors.
Endo Pharmaceuticals Inc.
CONTACT: Bill Newbould of Endo Pharmaceuticals Inc., +1-610-558-9800;Trine Hindklev, of the Chandler Chicco Agency for Endo PharmaceuticalsInc., +1-917-606-4361
