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Study shows Avinza improved sleep in patients with osteoarthritis pain

SAN DIEGO, CAL., Feb. 21, 2003 -- Ligand's Avinza (morphine sulfate extended-release capsules) improved overall quality of sleep in patients with chronic, moderate-to-severe osteoarthritis (OA) pain, compared to placebo, according to a study presented in poster form at the annual meeting of the American Academy of Pain Medicine (AAPM), in New Orleans.

In addition, Avinza given once daily in the morning improved overall quality of sleep compared to MS Contin (morphine sulfate controlled-release, Purdue Frederick) at weeks one and four of the four-week study.

"Sleep disturbances occur in 50-70% of patients with chronic pain," said lead author Jacques Caldwell, M.D., of Radiant Research in Daytona Beach, Florida. "Poor sleep may lead to increased pain, physical disability, and psychological disturbances that accompany chronic pain. In this study, the greatest improvements in the six sleep measures we evaluated were experienced by patients who took Avinza once daily in the morning. Once-daily Avinza offers a more convenient dosing schedule compared to twice-daily products."

Sleep measures were analyzed as part of a four-week study in which researchers evaluated the safety and efficacy of Avinza, MS Contin, and placebo in 295 patients with chronic, moderate-to-severe OA pain. Participants had failed to achieve adequate response to NSAIDs and acetaminophen or had previously received intermittent opioid therapy. Patients were given Avinza 30 mg once daily in the morning (QAM) or evening (QPM), MS Contin 15 mg twice daily, or placebo. No dosage adjustments were allowed.

The investigators evaluated six sleep measures weekly: overall quality of sleep, difficulty falling asleep, need for sleep medication, nightly hours of sleep, and frequency of waking due to pain during the night and morning. "It was striking that the largest sleep improvements, across all six measures, were reported by those patients receiving Avinza QAM," Dr. Caldwell said.

Avinza once-daily, taken in the morning or evening, provided improvements in all sleep measures at all time points relative to placebo, and statistically significant improvements were observed for a number of measures, including overall quality of sleep, at multiple time points. Avinza QAM also demonstrated a statistically significant improvement in overall quality of sleep compared to twice-daily MS Contin at weeks one and four.

Full safety and efficacy results of this study were published in The Journal of Pain and Symptom Management (Vol. 23, No. 4, 2002). As reported there, Avinza QAM, Avinza QPM and MS Contin twice daily demonstrated a statistically significant reduction in pain from baseline over the four-week study compared to placebo. Adverse events, most commonly nausea and constipation, were generally of mild or moderate severity, similar among the active treatments, and consistent with those commonly observed with opioid therapy.

Avinza was approved in March 2002 by the FDA for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid therapy for an extended period.

Source: Ligand Pharmaceuticals, Inc.

Posted: February 2003