CHADDS FORD, Pa., Oct. 27 /PRNewswire/ -- Today at the 66th Annual Assembly of the American Academy of Physical Medicine & Rehabilitation in Philadelphia, Endo Pharmaceuticals Inc. released data from an open-label pilot study of patients diagnosed with pain associated with mild-to-moderate carpal tunnel syndrome (CTS).
Results from the study demonstrated that the group of patients (n=20) treated with Endo’s topical analgesic patch, Lidoderm(R) (lidocaine patch 5%), applied to the painful wrist region achieved a 41.5 percent reduction in mean pain intensity as measured by the Brief Pain Inventory (BPI) at week zero (5.3/10 score) and at week four (3.1/10 score). In the group (n=20) given a single corticosteroid injection into the carpal tunnel, patients achieved a 43.8 percent reduction in mean pain intensity, as measured by the BPI, at week zero (4.8/10 score) and at week four (2.8/10 score). Data from a recently published randomized, controlled trial suggest that corticosteroid injections are better than surgical intervention in the short term and as effective as surgical decompression over the long term.
The results from today’s open-label study showed that 80 percent of patients treated with Lidoderm(R) reported they were “satisfied” or “very satisfied” with their treatment. Additionally, in the Lidoderm(R) group, the investigator rated improvements in 88 percent of the patients. Among those patients in the injection group, 59 percent of patients reported they were “satisfied” or “very satisfied” with their treatment, and the investigator rated improvements in 74 percent of the patients in this cohort.
“With increasing attention given to identifying alternative treatments for the pain associated with carpal tunnel syndrome, we were excited to find that a noninvasive, topical patch appeared to alleviate these patients’ carpal tunnel syndrome-related pain,” said lead author Srinivas Nalamachu, M.D., Mid-America Physiatrists in Overland Park, Kan., and assistant professor at the University of Medicine and Biosciences in Kansas City, Mo. He also noted that, “While encouraging, these results need to be confirmed in a prospectively randomized, double-blind, placebo-controlled trial.”
CTS is a neurological disorder, with CTS-related symptoms experienced by an estimated three percent of the U.S. population. It is a painful condition caused by a compressed nerve in the wrist, the hallmarks of which include paresthesia (tingling and “pins and needles” sensations, particularly at night), burning pain, as well as numbness in the hand and wrist that radiates up the arm. This progressive condition can worsen in some patients, causing worsening pain, increased tingling during the day and muscle weakness, experienced as diminished grip strength. Women are three times more likely than men to develop CTS.
About the Study
The four-week, randomized, parallel-group, open-label study evaluated 40 CTS patients aged 18-75 years old. Patients received up to three patches of Lidoderm(R) every 24 hours (changed daily) applied directly to the painful wrist region that overlies the carpal tunnel or a single injection of 0.5 cc lidocaine 1% and methylprednisolone acetate (Depo-Medrol(R)) 40 mg directly into the carpal tunnel at baseline. Both groups were composed of patients experiencing pain associated with mild-to-moderate carpal tunnel syndrome. No other analgesics for the treatment of CTS were allowed.
The efficacy of the two treatments was measured by a Brief Pain Inventory, Pain Quality Assessment Scale (a scale that measures patient’s pain qualities including “sharp,” “shooting,” “intense,” “numb,” “electrical,” “tingling,” “unpleasant,” “deep,” and other pain qualities), patient satisfaction and investigator’s global impressions. At the conclusion of the study, PQAS scores for all pain descriptors significantly improved in both the Lidoderm(R) group and the injection group when measured against their respective baseline levels (p<0.05).
In the study, both treatments were well tolerated, with treatment-related adverse events -- which were mild in severity -- reported in three patients per group (15%). Adverse events in the Lidoderm(R) group included rash, itching or burning sensation, while three participants in the injection group experienced hand numbness, tingling in their hands or injection-site pain.
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(R) patch, although the risk with this formulation has not been evaluated. It is important for patients to store and dispose of Lidoderm(R) 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 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. Depo-Medrol(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.
Endo Pharmaceuticals
CONTACT: Bill Newbould of Endo Pharmaceuticals, +1-610-558-9800; or KatieSilverwood, Cohn & Wolfe Healthcare, +1-212-798-9844
Web site: http://www.endo.com/
