Atlanta and Honolulu, November 9, 2006 – 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 KADIAN® (morphine sulfate extended-release) Capsules. These study results were highlighted in a presentation today 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 KADIAN® 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.
KADIAN® 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 KADIAN® 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 KADIAN® offers broad utility and is effective for even the most disabling types of chronic pain," said Dr. Weil.
The full study and this sub-analysis were supported by Alpharma Branded Products Division Inc., which has a growing franchise in the chronic pain market with KADIAN® (morphine sulfate extended-release) Capsules. KADIAN® is 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. KADIAN® capsules are not for use as a prn analgesic.
KADIAN® capsules contain an opioid agonist which is a Schedule II controlled substance. KADIAN® has an abuse liability similar to other opioid analgesics. This should be considered when prescribing or dispensing KADIAN® in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
Serious adverse reactions that may be associated with KADIAN® therapy in clinical use are those observed with other oral opioid analgesics and include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.
Patients who do not have a proven tolerance to opioids should be started only on the 20 mg strength, and usually increased at a rate not greater than 20 mg every other day. KADIAN® 100 mg capsules are for use in opioid-tolerant patients only.
KADIAN® capsules are to be swallowed whole and are not to be chewed, dissolved, or crushed. Taking chewed, dissolved, or crushed KADIAN® capsules or pellets leads to rapid release and absorption of a potentially fatal dose of morphine.
About Non-Surgical Orthopaedic and Spine Center, PC
Non-Surgical Orthopaedic and Spine Center, PC 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.
Reference
[i] Weil A, Sasaki J, Nicholson B, Ross E. Treatment of chronic neck pain using polymer-coated extended-release morphine sulfate capsules. [Poster]. Presented at: AAMP&R Annual Assembly; November 9-12, 2006; Honolulu, HI.