Two days of post-surgical pain relief now possible with just one shot

December 06, 2004

CHADDS FORD, Pa., December 6, 2004 - Beginning today, Endo Pharmaceuticals Inc. will initiate commercial shipments of the first and only single-dose epidural injection that can provide up to 48 hours of pain control to help ease pain for people undergoing major surgery in the United States. Every year, millions of Americans undergo painful procedures such as Cesarean sections, hip and knee replacements, and abdominal surgery. The many methods of relieving pain after such procedures include some that require catheters or IV (intravenous) lines. DepoDur™ (morphine sulfate extended-release liposome injection) is delivered as a single epidural shot using the innovative DepoFoam™ technology that allows the painkiller to be released into the epidural space over time. This may reduce the need for external tubes and pumps that are common with other forms of pain management following major surgery.

"DepoDur™ is good news for people having major surgery and is also a welcome change for physicians," said Gavin Martin, M.D., assistant clinical professor of anesthesiology, Duke University Medical Center. "With DepoDurTM, we can provide effective pain control for patients with fewer cumbersome devices, possibly improving the hospital experience and accelerating their recovery."

Unlike common formulations of morphine that are administered epidurally, DepoDur™ does not require an indwelling catheter for continuous pain relief. Indwelling catheters are tubes placed in a patient's spine to deliver pain medicine. Such catheters can make it difficult for patients to move around after surgery, can increase the risk of infection and can limit options for administration of anticoagulant (blood thinning) therapy. Another common method to relieve pain after surgery is by delivering the pain medication intravenously through patient-controlled analgesia pumps (IV PCA). Unfortunately, with IV PCA there can be equipment malfunction or patient error, leading to under- or over-delivery of medication and variable pain control. A recent meta-analysis reported in the Journal of the American Medical Association, encompassing three decades of research, showed that epidural analgesia provides significantly better postoperative pain control compared to parenteral opioids.

"Pain control after surgery is an important factor contributing to a fast recovery," said Martin. "In fact, research shows that patients whose post-surgery pain is managed properly may have less complicated rehabilitation periods and fewer chronic pain problems than those whose pain is not managed properly."

DepoDurTM: The Next Generation of Pain Relief after Surgery

Marketed by Endo Pharmaceuticals Inc., DepoDur™ is the first single-dose extended-release epidural formulation of morphine sulfate approved by the U.S. Food and Drug Administration (FDA) for the treatment of pain following major surgery. DepoDur™ employs SkyePharma's proprietary DepoFoam™ technology and is supplied as a ready-to-use suspension. DepoDur™ was developed by SkyePharma Inc. (LSE: SKP; Nasdaq: SKYE). Endo licensed the exclusive rights to market DepoDur™ in the U.S. and Canada from SkyePharma in December 2002 when the product was in Phase III clinical trial development.

The May 18, 2004 FDA approval of DepoDur™ was based on clinical data showing significantly improved outcomes in 876 patients undergoing major surgical procedures such as hip replacement, lower abdominal surgery and elective Caesarean section. In clinical trials, patients given DepoDur™ demonstrated lower pain intensity scores and reduced need for rescue medication. In these trials, efficacy was assessed for at least 48 hours and safety was assessed for up to 30 days after DepoDur™ administration.

DepoDur™ is indicated for single-dose administration by the epidural route, at the lumbar level, for the treatment of pain following major surgery. DepoDur™ is administered prior to surgery or after clamping the umbilical cord during Caesarean section. DepoDur™ is not intended for intrathecal, intravenous, or intramuscular administration. Administration of DepoDur™ into the thoracic epidural space or higher has not been evaluated and therefore is not recommended.

As with all opioids, the primary side effect of DepoDur™ is respiratory depression, especially in elderly and debilitated patients and in those with compromised respiratory function; accordingly, patients must be monitored for a least 48 hours, and the facility must be equipped to resuscitate patients. No other medication should be administered in the epidural space for at least 48 hours after an administration of DepoDur™. DepoDur™ is contraindicated in patients with known hypersensitivity to morphine or the product's components, and in those patients with respiratory depression, acute or severe bronchial asthma, upper airway obstruction, those who have or are suspected of having paralytic ileus, head injury or increased intracranial pressure and those who are in circulatory shock. Any contraindications for an epidural injection preclude the administration of DepoDur™. Patients with depleted blood volume receiving DepoDur™ may experience severe hypotension. The most common adverse events reported in clinical studies (>10%) were: decreased oxygen saturation, hypotension, urinary retention, vomiting, constipation, nausea, pruritus, pyrexia, anemia, headache and dizziness. DepoDur™ is a Schedule II controlled substance and is subject to abuse and diversion.
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About Endo

A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP), 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

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. Readers should evaluate any statement in light of these important factors.

Cohn & Wolfe

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