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Biopharmaceuticals

 News Release - May 4, 2006

Oxymorphone Studies Presented at American Pain Society Annual Meeting

Results from Pivotal Trials in Low Back Pain and Post-Surgical Pain

SAN ANTONIO, May 4 (HSMN NewsFeed) -- Endo Pharmaceuticals Inc. announced data from pivotal studies of oxymorphone extended-release (ER) and oxymorphone immediate-release (IR) tablets, its investigational oral opioid analgesics currently under U.S. Food and Drug Administration (FDA) review. The results of these studies were presented here at the 25th Annual Scientific Meeting of the American Pain Society (APS).

The two studies evaluating oxymorphone ER in opioid-naive and opioid- experienced patients suffering from chronic, moderate-to-severe low back pain showed that patients titrated to an effective and well tolerated dose of oxymorphone ER, and then randomized to receive either placebo or oxymorphone ER, could have their pain level maintained effectively at that same dose level of oxymorphone 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 multiple-dose oxymorphone IR study assessed time to discontinuation 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 oxymorphone IR to placebo (p<0.0001).

"These oxymorphone ER studies represent the first positive three-month, double-blind, placebo-controlled trials ever conducted with an opioid in chronic low back pain," said lead oxymorphone ER study investigator, 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. "The data from these trials suggest that oxymorphone ER offers a new treatment alternative for opioid-naive and opioid-experienced patients requiring a long-acting opioid for chronic moderate-to-severe low back pain for an extended period of time. They also demonstrate that in patients titrated effectively to the appropriate dose, oxymorphone ER offers a sustained treatment effect that does not appear to diminish over the study period of three months."

Rauck continued, "Overall, in these trials oxymorphone ER appeared to show a durable analgesic effect in a broad base of patient types. The availability of potential options such as oxymorphone ER is important in designing appropriate pain management strategies. This may be particularly relevant for those patients who take opioids and may need to change their treatment to achieve optimal pain relief."

Peter A. Lankau, Endo's president and chief executive officer, commented, "As a company that specializes in pain management, Endo has an ongoing commitment to provide patients with new and meaningful pain therapies. We are excited by the results of these oxymorphone ER and IR trials as we believe they demonstrate clinically significant results for improving the lives of patients in pain, with good tolerability. We look forward to the completion of the FDA's review of our pending new drug applications for both these important new products." He added that Endo expects to receive an action letter from the FDA on June 22, 2006. "If approved, we believe oxymorphone will present physicians with the first new oral opioid treatment for moderate-to-severe chronic pain in more than a decade, and would be an important option as well for those patients whose pain is not adequately addressed with their current therapy."

In all oxymorphone clinical studies, pain intensity was assessed using the Visual Analog Scale (VAS), one of the most frequently used pain measurement scales. VAS scale consists of a 100 millimeters (mm) scale ranging from no pain at all (0 mm) to the worst pain ImaginAble (100 mm).

Oxymorphone ER in Opioid-Naive Patients with Chronic Low Back Pain

This randomized, double-blind, placebo-controlled trial, conducted under the FDA's Special Protocol Assessment process (SPA), evaluated oxymorphone ER in opioid-naive patients with chronic, moderate-to-severe low back pain. Of 325 patients enrolled in the open-label phase, 205 patients were titrated to a stable dose of oxymorphone ER that reduced average daily pain from a mean of 70 mm at the start of treatment to less than or equal to 40 mm (on a 100 mm VAS) for 3 of 5 consecutive days. Patients were then randomized to either continue their stable dose of oxymorphone ER or placebo twice a day for 12 weeks. During the first four days following randomization, patients had unlimited access to oxymorphone IR as rescue medication; thereafter, rescue medication was limited to two 5 mg tablets per day, regardless of ER dose.

Study findings:

-- The mean change from baseline (pre-randomization) in average pain intensity was significantly greater (p <0.0001) among those patients who switched to placebo (mean 26.9 mm, median 29.0 mm VAS) when compared to those who continued on oxymorphone ER (mean 10.0 mm, median 2.0 mm VAS).

-- During the 12-week treatment period, discontinuations due to lack of efficacy were three times higher in the placebo group, 35.0%, when compared to the oxymorphone ER group, 11.4%. Dropouts due to adverse events were 8.6% in the oxymorphone group and 8.0% in the placebo group.

-- Of those patients who completed the study, 81.6% in the oxymorphone ER arm rated their pain medication as good, very good or excellent compared to 42.0% taking placebo.

-- In the study the adverse events were generally mild to moderate and included constipation, somnolence, nausea, headache, and dizziness.

Oxymorphone ER in Opioid-Experienced Patients with Chronic Low Back Pain

This randomized, double-blind, placebo-controlled study evaluated oxymorphone ER in opioid-experienced patients with chronic, moderate-to-severe low back pain whose pain was inadequately controlled on their previous opioid therapy (oxycodone ER, fentanyl patch and others). Of 250 patients enrolled in the open-label phase, 143 patients were titrated to a stable dose of oxymorphone ER that reduced average daily pain from a mean of 71 mm at the start of treatment down to less than or equal to 40 mm on a 100 mm VAS, for 3 of 5 consecutive days. Stabilized patients were then randomized to receive either placebo or continue with oxymorphone ER for a 12-week period. During the first four days following randomization, patients had unlimited access to oxymorphone IR as rescue medication; thereafter, rescue medication was limited to two 5 mg tablets per day, regardless of ER dose.

Study findings:

-- The placebo group experienced a significantly greater mean increase from baseline in pain intensity when compared to oxymorphone ER (mean 31.6 mm VAS versus 8.7 mm VAS; p<0.0001, median 38 mm and 2 mm VAS).

-- Nearly 80% of patients given oxymorphone ER rated their pain medication as good, very good or excellent compared to 32.8% of patients given placebo.

-- The median time to discontinuation due to lack of efficacy was significantly shorter in the placebo group compared to oxymorphone ER; 70.0% of patients taking placebo did not complete the study compared to 24.7% taking oxymorphone ER. Dropouts due to adverse events were 10% in the oxymorphone group and 11% in the placebo group.

-- In the study the adverse events were generally mild to moderate and included constipation, somnolence, nausea, headache, and dizziness.

Oxymorphone IR for Post-Surgical Abdominal Pain

The objective of this study was to assess the analgesic efficacy of single and multiple doses of oxymorphone IR compared to placebo in patients experiencing moderate-to-severe pain following abdominal surgery. In the trial, 331 patients were randomized to receive either oxymorphone IR (10 mg), oxymorphone IR (20 mg), oxycodone IR (15 mg) or placebo every four to six hours for up to 48 hours.

"In addition to its potential use as a complement to oxymorphone ER, we believe oxymorphone IR offers the possibility of an efficacious option on its own for treatment in acute pain, such as post-surgical pain," said David A.H., Lee, M.D., Ph.D., Endo's executive vice president and chief scientific officer.

Study findings:

-- The median time to discontinuation, due to lack of efficacy in the multiple-dose phase, was 17.9 hours with oxymorphone IR 10 mg, 20.3 hours with oxymorphone IR 20 mg, 24.1 hours with oxycodone IR and 4.8 with placebo.

-- In the single-dose phase, oxymorphone IR 20 mg provided better relief than placebo at most time points across a six-hour assessment period.

-- During multidosing, the mean current and average pain were significantly lower in patients treated with oxymorphone 10 and 20 mg compared to placebo (p<0.05).

-- Most adverse events were mild to moderate in intensity and included nausea, vomiting, pruritus and headache.

About Pain

Pain of all types is under-treated in our society; however, experts concur optimal management of chronic pain requires around-the-clock coverage with an analgesic agent. Approximately 50 million Americans suffer from chronic pain. Pain impacts a sufferer's daily functioning, quality of life and costs the United States more than $100 billion annually in health care expenditures and lost productivity. In fact, pain contributes to more than 50 million lost workdays each year.

About Oxymorphone

Oxymorphone is a semisynthetic micro-opioid agonist that has been formulated as a 12-hour extended-release (ER) tablet using a patented TIMERx® delivery system and as an immediate-release (IR) tablet. It has been studied in a wide range of chronic pain conditions, including low back pain, osteoarthritis pain, post-surgical pain and cancer pain. Endo is currently working with the U.S. Food and Drug Administration (FDA) to bring these products to the market for the treatment of moderate-to-severe pain. Oxymorphone ER and IR are currently under review by the FDA. The safety and efficacy of oxymorphone have not been established by the FDA. Endo developed oxymorphone ER using Penwest Pharmaceuticals' proprietary time-release technology, TIMERx®. The two companies provided funding for the oxymorphone ER studies. Oxymorphone IR is a proprietary product of Endo.

Oxymorphone is a Schedule II controlled substance and is subject to abuse and diversion. Respiratory depression is the chief hazard from all opioid agonists including oxymorphone preparations. Respiratory depression is a particular potential problem in elderly or debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia when even moderate therapeutic doses may dangerously decrease pulmonary ventilation.

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 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.


Source: Endo Pharmaceuticals

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