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Oxymorphone Long-Term Trial Data Presented at the American Academy Of Physical Medicine And Rehabilitation Meeting

Long-Term Open-Label Data Presented for Patients with Chronic, Moderate to Severe Low Back Pain and Chronic Moderate to Severe Osteoarthritis Pain

HONOLULU, HAWAII -- November 13, 2006 -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., presented data from several clinical trials of OpanaŽ ER (oxymorphone HCl) extended-release tablets CII. Results from these open-label studies were presented last week at the 67th Annual Assembly of the American Academy of Physical Medicine and Rehabilitation (AAPM&R).

OpanaŽ ER was approved in June 2006 by the U.S. Food and Drug Administration (FDA) for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

Two of the studies presented at the meeting were open-label, one-year extensions of placebo-controlled, blinded studies in patients with moderate-to-severe chronic low back pain and osteoarthritis pain. Study results demonstrated that OpanaŽ ER provided durable, effective pain relief in those patients who completed the full one year study period.

"Pain can be a chronic condition, and long-term trials involving pain treatments are extremely important," said David A.H. Lee, MD, PhD, Chief Scientific Officer of Endo Pharmaceuticals. "These trial results demonstrate that, in these patients with chronic pain resulting from lower back conditions or osteoarthritis, OpanaŽ ER provided safe, durable pain relief."

Additionally, data from a third open-label study showed that long-term treatment with OpanaŽ ER in opioid-naīve patients with moderate-to-severe chronic pain who completed the trial resulted in significant improvements in all pain quality of life measures, which were maintained throughout the course of the study period.

Dr. Lee continued, "Pain can often interfere with normal everyday activities and as a result can have a dramatic impact on patients' quality of life. This trial indicates that OpanaŽ ER minimized this disruption due to pain in these patients' daily lives."

Long-Term Effectiveness, Dosing and Tolerability of OpanaŽ ER in Patients with Chronic Lower Back Pain
This open-label extension study evaluated the effectiveness, dosing and tolerability of OpanaŽ ER in 93 patients who had completed a previous short-term, randomized, double-blind, placebo-controlled trial of Opana ER for moderate-to-severe chronic lower back pain. Patients were given OpanaŽ ER twice a day for one year with the dose adjusted as needed and were allowed OpanaŽ (immediate-release oxymorphone) as rescue medication for breakthrough pain as needed.

OpanaŽ ER provided durable effective pain relief throughout the one-year trial
90.2% of patients rated their pain medication as good, very good, or excellent at final visit
Pain was measured by the Brief Pain Inventory (BPI) 0-10 point scale (higher scores indicate worst pain). Throughout the one-year study, the average pain scores ranged from 4.4-4.9 and at final visit, it was 4.6 (ą2.1).

Mean daily doses of OpanaŽ ER and OpanaŽ increased from 93.7 mg to 135.2 mg and from 13.9 mg to 21.3 mg respectively over the one year period.

Commonly reported adverse events (<10%) included influenza, back pain, headache, upper respiratory tract infection, insomnia and urinary tract infection.

Long-Term Safety and Effectiveness of OpanaŽ ER in Patients with Chronic Osteoarthritis Pain
This open-label extension study evaluated the safety, effectiveness and dosing of OpanaŽ ER in 61 patients who had completed a previous randomized, placebo-controlled trial of OpanaŽ ER for moderate to severe chronic pain associated with osteoarthritis of the knee or hip. Patients taking active drug in the previous trial were given OpanaŽ ER twice a day at their prior dose for one year, whereas patients previously receiving placebo were given OpanaŽ ER 20 mg twice a day for one year.

OpanaŽ ER provided consistent and effective pain relief throughout the one-year trial
At each study visit 85% or more of patients rated their pain medication as "excellent," "very good," or "good".

Pain was measured by Pain Recall Scores (Visual Analog Scale [VAS]). Recall scores for least, worst, and average pain decreased over the first six weeks and stabilized thereafter.

There was only a modest increase in the mean daily dose over the one-year period; week 1 (49.3 mg) to week 10 (55.2 mg) and week 52 (62.0 mg).

Most discontinuations were due to nonserious adverse events, which were more commonly reported in previously opioid-naīve patients.

The most commonly reported adverse events (>10%) included constipation, nausea, somnolence, diarrhea, headache and arthralgia.

Effective Dose Titration and Long-Term Treatment with OpanaŽ ER Improves Quality of Life in Opioid-Naīve Patients with Chronic Moderate-to-Severe Pain
This open-label study evaluated OpanaŽ ER on pain reduction and improvements in quality of life in 60 patients during long-term treatment for moderate to severe chronic pain. In this study, 126 opioid-naīve adults with moderate or severe chronic pain who responded poorly to nonopioid analgesics were gradually titrated to a stable dose of OpanaŽ ER for three of five consecutive days. Stabilized patients continued OpanaŽ ER treatment for up to five additional months. Sixty patients completed the follow-up period. Immediate-release OpanaŽ was available as a rescue medication for breakthrough pain. Patients rated the impact of pain on their daily activities with a variety of quality of life measures using a 0-10 scale (0 represented no interference, 10 represented complete interference).

OpanaŽ ER provided significant improvements in all patient-reported pain quality of life measures (including activity, work, enjoyment of life, walking, sleep, mood, and relationships)
Treatment with OpanaŽ ER improved pain quality of life measures by 60%–70% and effects were maintained throughout the trial (P <.001 for all measures at all months).

The mean daily dose remained stable (range: 27.8–30.8 mg) with 68.1% of patients using immediate-release OpanaŽ as a rescue medication for breakthrough pain at some point during the course of the maintenance period. Mean daily dose of rescue medication ranged from 1.3-1.5 tablets per day.

Most common adverse events were constipation, nausea, and nasopharyngitis.

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

WARNING:
OpanaŽ 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.

OpanaŽ 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.

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

OpanaŽ 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.

OpanaŽ 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.

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

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

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

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. More than 50 million Americans suffer from chronic pain and 25 million suffer from acute pain. Pain costs the United States more than $100 billion annually. Additionally, pain contributes to more than 50 million lost workdays each year.

About Opana ER and OpanaŽ Tablets
OpanaŽ ER and OpanaŽ tablets were formulated using oxymorphone hydrochloride, a semisynthetic, pure mu-opioid agonist that had been available previously only as an injectable formulation. Both products have been proven to achieve effective relief in multiple moderate-to-severe pain models, in opioid-naīve and opioid-experienced patients. Both OpanaŽ ER and OpanaŽ are available by prescription only.

OpanaŽ ER's clinical profile has demonstrated that it can be dosed consistently on a twice-daily basis and is well-tolerated when titrated effectively. OpanaŽ ER has also shown 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. OpanaŽ 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. 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.

OpanaŽ ER has been studied in a wide range of chronic pain conditions, including low back pain, osteoarthritis pain, and cancer pain. Endo developed OpanaŽ ER using Penwest Pharmaceuticals' proprietary time-release technology, TIMERxŽ-N.

Immediate release OpanaŽ is indicated for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate. OpanaŽ has been studied in multiple post-operative pain models, including orthopedic and abdominal procedures. Immediate-release OpanaŽ is a proprietary product developed by Endo.


SOURCE: Endo Pharmaceuticals Holdings Inc.

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