Kadian alleviated chronic pain in patients unsuccessfully treated with well-known therapies

May 06, 2004

Atlanta and Vancouver, May 6, 2004 - Arnold Weil, M.D., founder of the Non-Surgical Orthopaedic & Spine Center, is presenting new data at the 2nd Joint Scientific Meeting of the American Pain Society and the Canadian Pain Society demonstrating that patients who were treated unsuccessfully with MS Contin® and OxyContin® found pain relief with Kadian, a sustained-release morphine sulfate. Kadian, approved to treat moderate-to-severe chronic pain, is designed with a unique polymer-coated pellet technology that avoids the initial release of morphine at the start of the dose and may reduce the "high" patients report experiencing with other oral pain-management therapies. The data also showed a broad range of significant improvements in physical and mental impairment for patients treated with the drug.

Dr. Weil is one of several researchers presenting data from the largest ever trial to examine the tolerability of a sustained-release opioid for the treatment of chronic, non-malignant pain.

"We have many patients who are not finding relief on current therapies, which can lead them to self-medicate. If they take more of the drug than instructed, a very dangerous situation can be created," said Dr. Weil. "In this study, we found that switching to the longer-acting opioid Kadian can improve pain relief, and in turn positively impact their overall quality of life, while actually reducing the number of times they need to take their medication. In light of the current national debate on abuse of prescription drugs for pain, we believe this data should impact the treatment of pain on the clinical level."

Some Patients Who Exceed Recommended Doses of OxyContin or MS Contin Find Relief with Kadian

A subset population from this community-based, prospective, randomized, open-label, blinded endpoint trial included 205 patients previously and unsuccessfully treated with MS Contin (n=55) and OxyContin (n=150). These patients, who presented with moderate/severe, chronic, non-malignant pain and a baseline visual numeric scale (VNS) 0-10 pain score >4, were randomized to either AM or PM once-a-day (QD) dosing with Kadian during a four-week treatment period. Dose adjustments were permitted, but twice-a-day (Q12h) dosing was withheld until week two. Final evaluations occurred at week four. Patients' assessment of pain was measured using a VNS scale and dosing frequency was recorded at week four. Prior to the start of the trial, 46 percent of the MS Contin patients in the study and 35 percent of the OxyContin patients had exceeded the twice-a-day recommended dosing interval in the prescribing information for each drug. After switching to Kadian, statistically significant improvements were seen at week four, when the patients' mean pain score was improved from baseline (p<0.001). There was an improvement of 2.7 points in those patients that were previously on MS Contin and an improvement of 2.2 points from the pre-study OxyContin patients. All patients were maintained on Kadian therapy within the recommended QD or Q12h dosing specified by the prescribing information.

Quality of Life (QoL) Measurements Showed Marked Improvement

Researchers, including Dr. Weil, also examined the ability of Kadian to alleviate pain, sleep disturbances and adverse events, as elements that can contribute to a patient's overall QoL. QoL was assessed using the SF36v2 Health Survey, while pain relief and sleep improvement were measured using a VNS 0-10 scale.

In the entire study population of 1,418 patients, statistically significant improvements were seen at week four in the physical (12 percent) and mental (15.6 percent) composite scores of the SF36v2 (p<0.0001), as well as the VNS scores for pain relief (32 percent; p<0.0001) and sleep (29 percent; p<0.0001). Adverse events were reported by 40 percent (n=563) of patients, with constipation (12 percent) and nausea (10 percent) being the most frequent.

"The patients in this study were all patients who had been on other treatments and were not able to find adequate relief," Dr. Weil explained. "We saw that patients taking Kadian improved in both mental and physical measures. This means they slept better, they were relieved of their pain and they have a better chance to gain control of their lives."

About Chronic Pain

It is estimated that 10-20 percent of the adult population suffers daily from non-malignant pain , and almost half of all Americans will seek medical care for persistent pain at some point in their lives. Chronic pain persists for longer than the usual recovery time for an injury or longer than six months. It can be mild or extreme; continuous or periodic; and last for weeks, months or even years. Chronic pain can be debilitating and greatly interfere with daily life.

About the KRONUS-MSP Trial

These findings are part of the data collected in the Kadian®: Response Of Non-malignant, Under-treated Subjects with Moderate/Severe Pain (KRONUS-MSP) trial. The largest ever trial to date to examine the tolerability of a sustained-release opioid for the treatment of chronic, non-malignant pain, KRONUS-MSP was community-based, prospective, randomized, open-label, with a blinded endpoint design. Investigators randomized 1,418 patients with chronic, non-malignant, moderate-to-severe pain and a baseline VNS pain score >4 to either an AM or PM QD regimen with sustained-release morphine sulfate (Kadian) for a four-week treatment period. All patients had a history of unsuccessful pain management. Dose adjustments were permitted; however, Q12h dosing was withheld until week two. Final evaluations occurred at week four.

About Non-Surgical Orthopaedic & Spine Center, P.C.

Non-Surgical Orthopaedic & Spine Center, P.C. was established in Atlanta in April 1993, specializing in the non-surgical treatment of musculoskeletal injuries. The practice has developed into one of the premier orthopaedic practices in the country, and is an industry leader for the non-invasive treatment of back and neck pain. The company's mission is to eliminate pain with a strong emphasis on injury prevention and rehabilitation.
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