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Endo Receives FDA Approval for Opana ER and Opana

CHADDS FORD, Pa., June 23, 2006 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. , today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the company's New Drug Applications (NDAs) for its extended- release and immediate-release formulations of oxymorphone hydrochloride. These products are now known under the trade names Opana ER Tablets and Opana Tablets.

A new oral extended-release opioid analgesic option for patients, Opana ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time and is not intended to be used on an as-needed basis. This is the first time oxymorphone will be available in an oral, extended-release formulation. Opana ER will be available in 5mg, 10mg, 20mg and 40mg Tablets. Opana (the immediate release version) is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate and will be available in 5mg and 10mg Tablets. Both products are expected to be commercially available in the U.S. in the coming weeks. Endo also plans to re- launch its oxymorphone hydrochloride injection under the new trade name in the hospital setting.

Peter A. Lankau, President and Chief Executive Officer, said, "We are pleased with the approval of Opana ER and Opana, which represent Endo's first internally developed NDAs to be granted FDA approval. The clinical program for Opana ER and Opana represents one of the most comprehensive ever conducted for an opioid analgesic, with more than 15 clinical trials enrolling over 3,000 patients. Further, Endo is very excited to be able to provide physicians and patients with these important new options for pain management."

Lankau added, "As a market leader in pain management, Endo is committed to the appropriate use of opioids, and we have worked closely with the FDA and external consultants to develop a program that gives health care providers and patients essential information and guidance on responsible opioid use."

Opana ER will compete in the market for long-acting, strong opioid analgesics, a $3.2 billion market in 2005. Its clinical profile demonstrates it can be dosed consistently on a twice-daily basis and is well-tolerated when titrated effectively. Opana ER has also demonstrated maintenance of effective pain control at a stable dose over the three-month period of the pivotal clinical trials, which the company believes highlights the durability of its analgesic effect. Experts agree that patients suffering from moderate- to-severe chronic pain which is present much or all of the day need around- the-clock coverage with an analgesic agent to sustain pain relief. Opana ER utilizes a patented delivery system that was specifically developed to provide continuous delivery of medication over a 12-hour period, helping patients maintain a steady level of pain relief. Opana ER and Opana were both formulated using oxymorphone hydrochloride, which had been available only as an injectable formulation. Both products have been proven to achieve effective relief in multiple moderate-to-severe pain models, in both opioid- naïve and opioid-experienced patients.

"The availability of Opana ER is great news for physicians as it adds to the arsenal of chronic pain management tools," said Richard Rauck, M.D., Clinical Associate Professor in the Department of Anesthesiology at Wake Forest University School of Medicine and Medical Director of the Center for Clinical Research in Winston-Salem, N.C. "Not only is the active ingredient in Opana ER one of the most extensively studied oral opioids in a clinical development program, its proven dosing every 12 hours can provide durable, lasting relief. Additionally, physicians may need to rotate opioids to effectively manage a patient's chronic pain, maintaining an acceptable balance between pain relief and side-effects."

Opana ER and Opana Clinical Trials

The clinical development program for Opana ER and Opana (immediate- release) included 15 Phase II and Phase III trials involving more than 3,000 patients. Among these trials were the first Phase III, placebo-controlled, double-blind studies ever conducted with an oral opioid for 12 weeks in chronic moderate-to-severe low back pain. These two studies -- one trial in opioid-naïve patients and the other in opioid-experienced patients -- showed that patients titrated to an effective and well-tolerated dose of Opana ER, and then randomized to receive either placebo or Opana ER, could have their pain level maintained effectively at that same dose level of Opana ER for a period of 12 weeks. These patients achieved a statistically significant reduction in average pain intensity compared to placebo (p<0.0001). The data confirm that in patients titrated effectively to an appropriate dose, Opana ER offered a durable analgesic effect in a broad base of patient types.

A multiple-dose study of immediate-release Opana assessed time to discontinuation for any reason and pain intensity in patients with moderate- to-severe pain following abdominal surgery. Results showed a statistically significant decrease in the primary endpoint (time to discontinuation for any reason) when comparing Opana to placebo (p<0.0001).

About Opana ER and Opana Tablets

Oxymorphone hydrochloride, the active ingredient in Opana ER and Opana, is a semisynthetic, pure .-opioid agonist that has been formulated as a 12-hour extended-release (ER) tablet and as an immediate-release tablet. Opana ER has been studied in a wide range of chronic pain conditions, including low back pain, osteoarthritis pain, and cancer pain. Opana has been studied as a treatment for acute pain conditions, such as post-surgical pain. Endo developed Opana ER using Penwest Pharmaceuticals' proprietary time-release technology, TIMERx. The two companies provided funding for the Opana ER studies. Immediate-release Opana is a proprietary product developed by Endo.

Important Safety Information

Opana ER and Opana are opioid agonists and Schedule II controlled substances with an abuse liability similar to morphine. Opana ER and Opana can be abused in a manner similar to other opioid agonists, legal or illicit.


Opana ER contains oxymorphone, which is a morphine-like opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics.

Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Opana ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Opana ER is an extended-release oral formulation of oxymorphone indicated for the management of moderate to severe pain when a continuous, around-the- clock opioid analgesic is needed for an extended period of time.

Opana ER is NOT intended for use as a prn analgesic.

Opana ER Tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed Opana ER Tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone.

Patients must not consume alcoholic beverages, or prescription or non- prescription medications containing alcohol, while on Opana ER therapy. The co-ingestion of alcohol with Opana ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone.

Opana ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery), or if pain is mild or not expected to persist for an extended period of time.

Opana ER and Opana are contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other ingredients of Opana ER and Opana; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated.

Respiratory depression is the chief hazard of Opana ER and Opana, particularly in elderly or debilitated patients.

The most common adverse drug reactions (.10%) in clinical trials for Opana ER were nausea, constipation, dizziness, vomiting, pruritus, somnolence, headache, increased sweating, and sedation. The most common adverse drug reactions (.10%) reported in clinical trials for Opana were nausea and pyrexia.

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Posted: June 2006