CHADDS FORD, Pa., Nov. 16 /PRNewswire/ -- Today at the American College of Rheumatology Annual Scientific Meeting in San Diego, Endo Pharmaceuticals Inc. released new data from an open-label clinical study evaluating Lidoderm(R) (lidocaine patch 5%) and the COX-2 inhibitor Celebrex(R) (celecoxib) 200 mg in patients with chronic low back pain. Lidoderm(R) is a topical analgesic patch approved to treat the pain of post-herpetic neuralgia, a chronic condition resulting from nerve damage caused by shingles.
Due to safety concerns in the fall of 2004 regarding the entire COX-2 inhibitor class of drugs, Endo, the study sponsor, voluntarily elected at that time to halt the study prematurely. Accordingly, the study was halted prior to reaching the original enrollment target. A post-hoc analysis of the data after four weeks of treatment, however, showed that of the patients treated in the Lidoderm(R) group (n=36), 50% experienced a 30% or greater improvement in average daily pain intensity. (Studies have reported that 30% or greater reductions in pain intensity are clinically meaningful to pain patients.(1)) In the Celebrex(R) group (N=38), 42.1% experienced a 30% or greater improvement in average daily pain intensity. Furthermore, 36.1% of patients treated with Lidoderm(R) experienced a 50% or greater improvement in average pain intensity. In the Celebrex(R)-treated group, 26.3% of the patients experienced a 50% or greater improvement in average pain intensity.
Results of the study also showed that after four weeks of treatment, 75.8 percent of the patients (n=33) treated in the Lidoderm(R) group reported they were either very satisfied or satisfied with their treatment. After four weeks of treatment, 72.2 percent of patients (n=36) from the Celebrex(R) group reported they were either very satisfied or satisfied with their treatment. In addition, at four weeks both groups experienced improvement in quality of life including general activity, mood, walking ability and sleep.
“There is a critical need for new options for treating patients with chronic low back pain,” said Bruce Nicholson, M.D., of Penn State University School of Medicine and director of the Division of Pain Medicine at Lehigh Valley Hospital. “Although today’s results need to be confirmed in larger, double-blind, placebo-controlled studies, I am encouraged by these findings.”
Low back pain, a common painful condition, affects approximately two- thirds of adults at some time during their lives. If left untreated, low back pain can cause unnecessary suffering and negatively affect a person’s life at home and on the job.
Dr. Nicholson added, “It is encouraging to see Lidoderm(R) being studied as a treatment for chronic low back pain, and I look forward to seeing the results of ongoing clinical trials.”
About the Study
The randomized, open-label, active-control, parallel-group pilot study, which intended to enroll 200 patients, enrolled 97 patients experiencing low back pain for at least three months with or without radiation to the buttock or below, and who were evaluated for efficacy of treatment. After a seven- to 14-day wash-out period, during which all analgesic medications, as well as chondroitin and glucosamine, were discontinued, patients with an average daily pain intensity score of greater than or equal to 5 on a scale of 0 to 10, for three of five consecutive days prior to the baseline measures, were randomized to 12 weeks of treatment. They received either two Lidoderm(R) patches directly to the most painful area of the back (41 patients) once daily for 24 hours at approximately the same time or Celebrex(R) 200 mg once daily (38 patients). Efficacy measures included the Brief Pain Index (BPI), the Oswestry Disability Index, and pain interference on quality-of-life.
In the study, both treatments were generally well tolerated, with treatment-related adverse events reported in 16 patients in the Lidoderm(R) group and 20 patients in the cohort of patients treated with Celebrex(R). The most commonly reported treatment-related adverse events in the Lidoderm(R) group included application-site reactions and in the Celebrex(R) group included gastrointestinal disorders and nausea.
About Lidoderm(R)
Lidoderm(R) (lidocaine patch 5%) is a topical analgesic patch approved by the U.S. Food and Drug Administration (FDA) in 1999 to treat the pain associated with post-herpetic neuralgia (PHN), a chronic condition resulting from nerve damage caused by shingles. Lidoderm(R) produces an analgesic effect by the penetration of lidocaine. Lidoderm(R) should only be applied to intact skin. Lidoderm(R) is contraindicated in patients with a history of sensitivity to local anesthetics (amide type) or any product component. The potential exists for a small child or a pet to suffer serious adverse effects from chewing or ingesting a new or used Lidoderm patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of Lidoderm out of the reach of children and pets.
Excessive dosing of Lidoderm(R) could result in increased absorption of lidocaine and high blood concentrations leading to serious adverse effects. Lidoderm(R) should be used with caution in patients with severe hepatic disease, pregnant or nursing mothers, or those receiving Class 1 antiarrhythmic drugs (such as tocainide and mexiletine) because of the potential for serious adverse effects. Avoid contact of Lidoderm(R) with the eye. If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns. During or immediately after Lidoderm(R) treatment, application-site reactions may occur. The most commonly reported post-marketing adverse events are: application-site erythema, burning sensation, dizziness, erythema, headache, nausea, pain exacerbated, pruritus (itching), rash, and rash erythematous.
The FDA-approved dosing for Lidoderm(R) is up to three patches applied for up to 12 hours within a 24-hour period. Lidoderm(R) has not been approved by the FDA for any indications other than for the relief of pain associated with PHN, and its safety and efficacy in other indications have not been established.
Lidoderm(R) is a registered trademark of Hind Healthcare Inc. Celebrex(R) is a registered trademark of Pfizer Inc. 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 April 30, 2004, as amended and in Endo’s Registration Statement on Form S-3 filed with the SEC on September 2, 2005, as amended . Readers should evaluate any statement in light of these important factors.
(1) Farrar, James T. et al. Clinical Importance of Changes in Chronic
Pain Intensity Measured on an 11 Point Numerical Pain Rating Scale.
Endo Pharmaceuticals Inc.
CONTACT: Bill Newbould of Endo Pharmaceuticals Inc., +1-610-558-9800; orKatie Silverwood of Cohn & Wolfe Healthcare, +1-212-798-9844, for EndoPharmaceuticals Inc.
Web site: http://www.endo.com/
