SAN ANTONIO, May 4 /PRNewswire/ -- KADIAN(R) improves pain scores and
pain symptoms in arthritis and fibromyalgia syndrome (FMS) patients to the
same degree as patients with other moderate to severe chronic non-malignant
pain states, according to two supplemental analyses presented at the 25th
Annual Scientific Meeting of the American Pain Society.
    "Opioid use in this patient population may be considered after
first-line treatment has failed and these data further support this
conclusion," said study investigator Bruce Nicholson, MD, Director, Pain
Specialists of Greater Lehigh Valley, Inc. "KADIAN(R) demonstrated efficacy
and safety in these patient groups."
    These sub-analyses are from a large, demographically diverse,
community-based study population. A total of 1,428 patients were enrolled
by investigators at 202 community-based pain centers. Of these, 1,418
non-malignant pain patients were included in the safety population, and
1,150 patients were included in the ITT population. The mean age of the
patient population was 47.9 plus or minus 12.5 years (range, 19-89 years).
Overall, 60.3 percent of the patients were women, and 89.6 percent were
white (7.4 percent black, 2.0 percent Hispanic, 0.5 percent Asian, and 0.5
percent other).(1)
    In the first sub-analysis patients whose moderate-to-severe chronic
pain had been undertreated were given KADIAN(R) for four weeks. These
patients were compared with patients with other non-malignant pain states
(OP). Arthritis patients (n=98; 89 osteoarthritis, 9 rheumatoid) taking
KADIAN(R) experienced a 25 percent improvement in pain scores and a 19
percent improvement in sleep scores (p<0.001). The arthritis pain patients
had similar results to the OP patients in the study. Additionally, patients
saw a significant improvement in patient and physician assessment of
therapy and quality of life scores.(2)
    In the second sub-analysis, KADIAN(R) significantly improved
moderate-to- severe chronic pain symptoms in patients with a diagnosis of
fibromyalgia syndrome (FMS) who had been previously undertreated.
Eighty-one FMS patients who had participated in the larger study (n=1428)
and used KADIAN(R) were compared with data on patients with other pain
types after four weeks. Patients began once-daily dosing, with dose
adjustments after one or two weeks, and could switch to twice-daily dosing
after two weeks, if needed. Patients taking KADIAN(R) experienced a 24
percent improvement in pain scores and a 15 percent improvement in sleep
scores (p<0.05). Patients with FMS initially reported lower scores in their
overall quality-of-life (QoL) scales than those with non-malignant pain,
but by week four both patient groups showed similar improvements in QoL.(3)
    The most common adverse events in both analyses were constipation and
nausea. In the arthritis pain sub-analysis, constipation was reported by 17
percent of arthritis patients and 12 percent of OP patients; nausea was
reported by 11 percent and 8 percent of patients, respectively.(4) In the
FMS arm, constipation was reported by 14 percent and 12 percent of FMS and
OP patients; nausea was reported by 10 percent and 10 percent of patients,
respectively.(5)
    This full study and these sub-analyses were supported by Alpharma
Branded Products Division Inc., formerly known as Faulding Laboratories
Inc. Alpharma Branded Products Division has a growing franchise in the
chronic pain market with KADIAN(R) (morphine sulfate extended-release)
Capsules. KADIAN(R) 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(R) capsules contain an opioid agonist which is a Schedule II
controlled substance. KADIAN(R) has an abuse liability similar to other
opioid analgesics. This should be considered when prescribing or dispensing
KADIAN(R) 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(R) 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(R) 100 mg capsules are for use
in opioid- tolerant patients only.
    KADIAN(R) capsules are to be swallowed whole and are not to be chewed,
dissolved, or crushed. Taking chewed, dissolved, or crushed KADIAN(R)
capsules or pellets leads to rapid release and absorption of a potentially
fatal dose of morphine.
    Patients must not consume alcoholic beverages while on KADIAN(R)
therapy. The use of alcohol while taking KADIAN(R) may result in a
significant increase in the release rate and absorption of a potentially
fatal dose of morphine.
    References
     (1) Nicholson B, Ross E, Weil A, Sasaki J, Sacks G. Treatment of chronic
         moderate-to-severe non-malignant pain with polymer-coated extended-
         release morphine sulfate capsules. Curr Med Res Opin. 2006;
         22:539-550.
     (2) Ross E, Nicholson B, Sasaki J, Weil A. KADIAN(R) (extended-release
         morphine sulfate) in the treatment of arthritis pain. [Poster].
         Presented at: American Pain Society 25th Annual Meeting; May 3-6,
         2006; San Antonio, TX.
     (3) Nicholson B, Ross E, Sasaki J, Weil A. Treatment of fibromyalgia pain
         using KADIAN(R) (extended-release morphine sulfate capsules).
         [Poster]. Presented at: American Pain Society 25th Annual Meeting;
         May 3-6, 2006; San Antonio, TX.
     (4) Ross E, Nicholson B, Sasaki J, Weil A. KADIAN(R) (extended-release
         morphine sulfate) in the treatment of arthritis pain. [Poster].
         Presented at: American Pain Society 25th Annual Meeting; May 3-6,
         2006; San Antonio, TX.
     (5) Nicholson B, Ross E, Sasaki J, Weil A. Treatment of fibromyalgia pain
         using KADIAN(R) (extended-release morphine sulfate capsules).
         [Poster]. Presented at: American Pain Society 25th Annual Meeting;
         May 3-6, 2006; San Antonio, TX.

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