New Analysis Shows Kadian Alleviates Chronic Moderate-To-Severe Non-Malignant Neck Pain

November 18, 2006 – 12:10 pm | posted in Clinical Trials / Drug Trials, Pain / Anesthetics, Rehabilitation

Patients with moderate-to-severe chronic neck pain who had inadequate relief on previous analgesic regimens attained improvements in pain, sleep and quality of life when treated with the long-acting opioid analgesic KADIANï¿½Â® (morphine sulfate extended-release) Capsules. These study results were highlighted in a presentation on 15-Nov-2006 at the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Annual Meeting in Honolulu.

Study investigators analyzed a subset of 227 adult patients with neck pain who participated in a larger prospective, randomized, open-label study of KADIANï¿½Â® for moderate-to-severe, non-malignant pain in patients who had inadequate relief with previous analgesics (N=1,428). Primary efficacy outcomes included pain intensity and sleep interference (0-10 scales: 0=no pain, 10=most pain), quality of life (SF-36v2TM Physical [PCS] and Mental [MCS] Component Summary scores), patient and clinician global assessments of therapy (-4 to +4 scales: -4=completely dissatisfied, +4=completely satisfied).[i]

“Up to 50 percent of adults will suffer from chronic neck pain - and its associated disability - at some point in their lives. These data are encouraging for the millions of Americans with persistent neck pain who cannot find relief with other analgesics,” said Arnold J. Weil, M.D., principal investigator of the study and founder of the Non-Surgical Orthopaedic and Spine Center, PC in Atlanta, GA. 6

KADIANï¿½Â® is an extended-release formulation of morphine sulfate that provides 12 to 24 hours of pain relief and is indicated for once-daily (QD) or twice-daily (BID) dosing.

Patients in the study were randomized to receive KADIANï¿½Â® once-daily (morning or evening) for four weeks. Doses were based on previous analgesic regimens, with titration permitted after week one or two, and switching to twice-daily was allowed after week two. After four weeks, patients with chronic neck pain reported a 30.7 percent reduction in pain intensity versus baseline (p<0.001).

* Sleep interference scores improved by 27.3 percent versus baseline (p < 0.001)

* Mental Component Summary scores improved from 33.0 -11.9 at baseline to 38.7 - 12.7 (p < 0.001)

* Physical Component Summary scores improved from 29.2 - 7.9 at baseline to 32.8 - 8.6 (p < 0.001) * Patient global assessment scores improved from -1.1 - 2.0 to +1.5 - 1.9 (p < 0.001)

The most common adverse events reported by patients with chronic neck pain were constipation (11.5 percent), nausea (11.5 percent), dizziness (4.4 percent), pruritus

(4.0 percent), somnolence (3.1 percent) and vomiting (3.1 percent).

“The improvements in quality of life outcomes, and the fact that improvement rates were similar to those of patients with other non-malignant pain types, suggest that KADIANï¿½Â® offers broad utility and is effective for even the most disabling types of chronic pain,” said Dr. Weil.

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